News

Probiotics Receive Conditional Recommendation

Babies born preterm—before 37 weeks of gestation—account for approximately 15 million births worldwide each year, according to the World Health Organization. This extremely vulnerable population of infants are at risk for multiple complications, including susceptibility to NEC, a serious disease that causes tissue damage to the intestines resulting from bacteria invading the intestinal walls. The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) working group on probiotics and prebiotics conducted an extensive review of the clinical evidence surrounding probiotic use in the NICU. The working group published guidelines conditionally recommending specific strains of probiotics, including the combination of B.infantis (BB-02), B.lactis (BB-12), and S.thermophilus (TH-4), as it might reduce NEC stage 2 or 3 in preterm infants (low certainty of evidence), provided all safety conditions are met. The safety conditions include use of strains without transferable antibiotic resistance genes, correct strain identity and lack of product contamination that were manufactured in accordance with good manufacturing practices (GMPs). The authors note that only a limited number of strains have shown clinical effectiveness in this patient population. The guidelines also highlight the importance of assessing the safety in overall product manufacturing. This includes understanding a probiotic’s potency, stability and purity. Preterm infants are deprived of adequate time in utero for growth of critical organs, including the digestive system where 70% of the immune system resides. In addition to an underdeveloped digestive system, preterm infants can experience imbalances in gut bacteria. The use of probiotics in this population may reduce the incidence of NEC. Currently ~20% of NICUs in the United States use probiotics when treating and caring for preterm infants. “A high-quality probiotic that has been studied in preterm infants would equip clinicians in the NICU with the ability to mitigate some of the risks associated with preterm births, including necrotizing enterocolitis, that can affect these babies,” said Dr Karyn Wulf, MD, MPH, Pediatric Medical Director at Abbott. “The ability for medical professionals to provide best-in-class care using nutrition allows them to proactively support a strong start in life.”

For Mothers With Coronavirus, Baby's First Coo Is Over the Phone

"It's a girl and she is fine, we all are fine," said Rayhona, 23. "They have shown her to me on a smartphone." More than 150 babies have been born to mothers with suspected coronavirus infections at Moscow's City Clinical Hospital Number 15, and the hospital says not a single newborn caught the infection. But to achieve that, the babies are separated from their mothers at birth, breastfeeding is banned, and the mothers are kept quarantined in a ward for two weeks. Rayhona wore a mask and was hooked up to medical devices, sharing a room with another new mother also suspected of carrying the virus. The mothers "are admitted with some respiratory distress already and we need to be very professional to determine when to deliver the baby and how to deliver it," the hospital's head doctor, Valeriy Vechorko, said. "I can say this for sure — we did not have a single transmission of the virus to a baby." Until they are released from quarantine, mothers can communicate with their new babies only via video calls. The mothers "are scared - more scared than usual at least — as they are worried not only about themselves but about their baby as well," said hospital cardiologist Olga Lapochkina. "We try to keep mothers in touch with the babies via video links. Doctors show them and it really helps."

Companies Reinforce Partnership

Masimo and Royal Philips, both global leaders in patient monitoring, announced that they have reinforced their partnership, whereby Philips will integrate additional Masimo measurement technologies into select IntelliVue MX-series multi-parameter monitors, to help clinicians assess cerebral oximetry and ventilation status. Core Masimo noninvasive measurements, such as SET Measure-through Motion and Low Perfusion pulse oximetry and advanced rainbow SET Pulse CO-Oximetry parameters like noninvasive hemoglobin (SpHb), have long been available on a wide range of Philips multi-parameter monitors. In 2016, Masimo and Philips entered into a multi-year business partnership involving both companies' innovations in patient monitoring and therapy solutions. Now, in 2020, Philips becomes one of Masimo's first industry partners to launch additional advanced Masimo measurements, NomoLine and O3, in their own patient monitors, sharing Masimo's expertise in capnography and regional cerebral oximetry with caregivers and patients around the world. NomoLine capnography and O3 regional oximetry measurements are available now on Philips MX500 and MX550 monitors in select markets throughout the world, and are also available directly from Masimo on its Root Patient Monitoring and Connectivity Platform and when connected to select Philips patient monitors via Philips' IntelliBridge module: NomoLine "no-moisture" sampling lines are designed for low-flow applications and can be used in a variety of clinical scenarios and care settings, on both intubated and non-intubated patients of all ages, in both low- and high-humidity applications. O3 regional oximetry may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.

HCV-Exposed, Uninfected Infants Show B-Cell Changes

Many uninfected babies born to mothers with chronic hepatitis C virus (HCV) infection may have already fought off the virus themselves, new research suggests. Infants exposed to the virus but not infected had immune system changes similar to those of HCV-infected infants, including high numbers of virus-specific IgG-secreting B cells, more IgA-positive plasma cells and upregulation of CD40, compared with unexposed and uninfected infants, Dr Niklas K. Bjoerkstroem of Karolinska University Hospital in Stockholm and colleagues found. "It seems to be a specific thing that happens within the B cells within these exposed children," Bjoerkstroem said. "It gives us some insight into why it's such a rare instance that hepatitis C is vertically transmitted." The risk of mother-to-child transmission (MTCT) in pregnant women with HCV is not clear, but it is estimated at approximately 5%, lower than for chronic hepatitis B virus and HIV, Dr. Bjoerkstroem and his team note in Gut. Some uninfected children born to mothers with HCV have HCV-specific T-cell responses, they add. To investigate B-cell-mediated immunity and HCV exposure, the authors looked at 55 mothers and their babies delivered at a hospital in Saint Petersburg, Russia, from 2012 to 2016. Infants underwent peripheral blood mononuclear cell (PBMC) sampling at birth and at six, 12 and 18 months. Forty of the mothers were HCV-RNA positive when the babies were born and 15 were negative, indicating that they had cleared the virus. Their infants were classified as unexposed. Among the 40 exposed infants, three became HCV-RNA positive during the follow-up period, and were classified as infected.

Children who became infected had higher mean levels of HCV-specific Ig-G secreting B cells than the children who were exposed but uninfected and the unexposed group. Mean levels of HCV-specific Ig-G secreting B cells were similar for the exposed but uninfected and the unexposed groups, but some exposed individuals had "robust responses." IgA-positive plasma cells were identified in 28.9% of infected children, 29.7% of exposed children and 15.1% of unexposed children, with a similar pattern for IgG-positive plasma cells. Infected children also had changes in myeloid immune cells and natural killer cells and a soluble factor profile with high levels of inflammatory cytokines and chemokines, none of which were seen in the exposed group.

COVID-19 Severity in Pregnancy Appears Lower Than H1N1

Unlike past respiratory illnesses, pregnancy does not seem to put women at risk of worse outcomes from COVID-19, according to the first 6 weeks of births to women in the UK during the COVID-19 era.

"When we actually looked at our data in nonpregnant women of the same age, the outcomes look to be pretty similar for [mothers]" with COVID-19, study coauthor Marian Knight, MBChB, DPhil, professor of maternal and child health at the University of Oxford, United Kingdom, said. The data, currently available on a pre-print database, also suggest that more severe outcomes are more likely in later pregnancy, which Knight said should support guidance that women in the third trimester be vigilant with physical distancing, masking, and hand hygiene to avoid acquiring SARS-CoV-2 in the first place. The paper has not been peer-reviewed and therefore the findings should be taken as preliminary until it is accepted. The data may also temper concerns raised in early case reports on miscarriage and other poor outcomes. "Most of the publications in pregnancy have been case series, and we've really had no idea how representative they are of all the women affected," she said. "These results can be reassuring" that poor outcomes may indeed be less common than the current literature suggests.

Endowment Announced

As part of an ongoing commitment to the advancement of respiratory care, Dräger announced that it has granted the American Respiratory Care Foundation (ARCF) a $50,000 endowment to support the Craig D Smallwood Early Investigator Fellowship. This newly established program, which will be announced at the 2020 American Association for Respiratory Care (AARC) International Congress in Orlando, honors the late Craig D Smallwood, PhD, RRT, who died unexpected at the age of 36 in April 2020. Dr Smallwood was an innovative, collaborative and productive researcher who served as a mentor to up-and-coming researchers in the field of respiratory care. Before his untimely passing, he was working on the design and deployment of respiratory assist devices for treatment of COVID-19 patients in the developing world. The ARCF fellowship is designed to provide the chosen fellow with financial, experiential and mentoring resources; thereby continuing Dr Smallwood’s tradition of promoting the role of the respiratory therapist in supporting neonatal and pediatric research. “We are very pleased to receive such generous support from Dräger, a forward-thinking company that understands the importance of mentorship in respiratory care,” said ARCF Chairman Michael Amato. “This unique program remembers the valuable contributions of Dr Smallwood, and will help prepare the next generation of researchers. By supporting the ARCF, Dräger is investing in the future of respiratory care.” Dräger is one of several companies in the respiratory industry to establish an endowment to the ARCF for the purpose of creating research fellowships. This program recognizes the ongoing need for effective clinical research specifically to support neonatal and pediatric patients. “Technology advancement, innovation and new clinical practices require research,” said President and CEO for Dräger in North America, Lothar Thielen. “Establishing an annual award to support neonatal/pediatric research fosters an environment of collaboration and continues the scholarly work necessary to advance and improve patient outcomes.”

Birth Rates Fall

The number of babies born in the US hit the lowest level in more than three decades in 2019, continuing a five-year downward trend, according to a new federal report. The report on provisional data from the Centers for Disease Control and Prevention indicates notable birth and population measures reached record lows in 2019. American women, for example, are now projected to have about 1.71 children over their lifetimes – down 1% from 2018 and below the rate of 2.1 needed to exactly replace a generation. "The (total fertility) rate has generally been below replacement since 1971 and consistently below replacement since 2007," the report says. In all, the US saw nearly 3.75 million births last year, down 1% from 2018 and the lowest level since 1985, according to the CDC. Births fell among women of most races, though they rose 3% for women who were Native Hawaiian or other Pacific Islander. Births remained largely level for Hispanic women. The US birth rate – which measures the number of births per 1,000 women and girls between the ages of 15 and 44 in a given year – sat at 58.2 in 2019 for another record low, according to the report. Its continual decline has been driven in part by a 73% plummet in the teen birth rate since 1991. That rate fell another 5% in 2019, reaching 16.6 per 1,000, the report notes. Birth rates also fell for women in their 20s and early 30s in 2019, but rose for women in their early 40s. "The rate for (women 40 to 44 years old) has risen almost continuously since 1985 by an average of 3% per year," the report says. Trends in birth outcomes also continued in 2019: The preterm birth rate rose for the fifth year in a row, reaching 10.23%, while the cesarean section rate fell to 31.7% from 31.9%. The low-risk C-section rate – measuring C-sections among women giving birth for the first time to a single baby, born after reaching term and in the head-first position – fell to 25.6% from 25.9%. The federal government's Healthy People goals say the low-risk C-section rate should be no more than 24.7% by 2020, and there's significant variation in C-section rates at the state and county levels.

Astarte Medical has an upcoming webinar, Preterm Infant Growth Assessment — Metrics That Matter

Featured Speakers: Dr Tanis Fenton and Dr Bill Hay on June 10, 2020, at 4:00 p.m. ET.
Topics of discussion will include:

• Findings from their recent publication - Extrauterine growth restriction" and "postnatal growth failure" are misnomers for preterm infants published March 25, 2020
• Definition of Extrauterine Growth Restriction (EUGR)
• Proper growth assessment and metrics that matter

Registration and Complete Event Details: https://astartemedical.webinarninja.com/live-webinars/327916/register

Study Shows Reduced Risks

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk–based nutritional products, announced that a subgroup analysis of a randomized, multicenter clinical study demonstrated a fivefold reduced risk of certain serious complications and death, and greater increases in head circumference, which suggests better brain growth, using Prolacta’s 100% human milk–based fortifier in place of cow milk–based fortifier among preterm infants. All study infants were fed only their mother’s milk, in addition to either human- or cow-milk-based fortifiers and were treated in a neonatal intensive care unit (NICU). The analysis was conducted to more closely compare feeding protocols used in NICUs today and represents one of the only studies of preterm infant feeding protocols ever to directly compare fortifiers made from either human milk or cow milk among infants whose only other source of enteral nutrition is milk from their mothers.   The study, “Preterm Infants Fed Cow's Milk–Derived Fortifier Had Adverse Outcomes Despite a Base Diet of Only Mother's Own Milk,” was published in Breastfeeding Medicine and found the following health outcomes among preterm infants who received Prolacta’s 100% human milk–based fortifiers:

• 13% greater head circumference gain, which is used as a measure of brain growth
• 5.1-fold reduced risk of surgery and death due to necrotizing enterocolitis (P = 0.014)
• Comparable weight and length gain

“Those fed the human milk–derived fortifier were significantly advantaged in terms of a reduced incidence of morbidity,” wrote the study authors, who were led by Alan Lucas, MD, Professor at the Institute of Child Health, University College London in the United Kingdom. Many studies, including the original study2 from which this analysis was derived, compared human- and cow-milk-based fortifiers in infants fed various combinations of human milk (from either their mother or donors) and cow milk–based preterm formula. However, many healthcare professionals prefer direct clinical comparison for the specific effects of a 100% human milk–based fortifier vs a cow milk–based fortifier, since avoidance of exposure to cow-milk proteins is one likely reason 100% human milk–based fortifiers are so beneficial. Based closely on the methods by which preterm infants are currently being fed in NICUs worldwide, the subgroup analysis focused specifically on the 114 infants who received their mother’s milk plus either:

• Prolacta’s 100% human milk–based fortifier (82 infants)
• Cow milk–based fortifier (32 infants)

“The original Sullivan study has been criticized for not representing current NICU feeding practices which prioritize mother’s milk or donor human milk over cow milk–based preterm formula. The Lucas subgroup analysis removed that variable to provide a head-to-head comparison of human- vs cow-milk-based fortifiers mixed with a base of mother’s milk. It demonstrated, with statistical significance, that the cow-milk-based fortifiers alone lead to adverse outcomes, while preterm infants fed Prolacta’s human milk–based fortifier achieved the same positive results including fewer complications as demonstrated in the original study. This subgroup analysis also found additional improvements in head growth, which is an indirect measure of brain growth, in the infants receiving Prolacta’s fortifier,” said Melinda Elliott, MD, Chief Medical Officer, Prolacta Bioscience.

Neotech Products Re-releases Disposable Ocular Exam Kit

Back by popular demand, Neotech Products is excited to announce the re-release of the Ocular Exam Kit Disposable Speculum and Depressor. “After numerous requests by clinicians for a disposable alternative, we made the decision to bring back this innovative and unique product,” said Executive Director of Sales & Marketing, Judy McCrary. Conceived by Dr David Sami, Pediatric Ophthalmologist, our specula and depressor was developed for single use per eye. This helps to reduce the risk of cross contamination and eliminate the need to re-sterilize. “One of the many benefits of the Neotech Ocular Exam Kit is that due to its disposability, it does not incur the normal re-sterilization costs that standard exam kit tools do,” McCrary said. The Ocular Exam Kit is disposable, sterile, and ready to use. Its unique speculum is designed to lock in place with eyelid pressure, allow unrestricted view, and open and close with ease. The speculum is available in two sizes—Neonatal and Standard. The two-sided depressor features an innovative texture intended to gently grip the conjunctiva.

Utility Device Holder with C-clip Attachment Available

Neotech Products unveiled the NeoHug Utility Device Holder is now available with a C-clip attachment for IV poles. “We had increased interest in departments that didn’t have a surface to adhere the suction cup [of the original NeoHug] to. Our incredible engineering team at Zewski Corp got to work creating this new attachment for the NeoHug. Their skilled team took the challenges in needing an adaptation and made them into the reality,” said Sara Dimmitt, Manager of Business Development. The new C-clip attaches to most IV poles, snaps on and off, and features a ribbed design to minimize slipping. “The C-clip is great for pediatrics and mobile patients to hold tubing or needed supplies,” Dimmitt said. NeoHug is also available with a large suction cup that attaches to most smooth, flat surfaces. It offers a strong hold that withstands heat and humidity, and features a tab for easy removal. Like the C-clip, the suction cup allows for repeated repositioning with no adhesive. The playful chimp design adds some color to your unit, five bright colors in fact! The bendable arms are designed to hold a variety of lightweight items, making it ideal for holding pacifiers, suctioning tips, tape, tubing, and more!

Observational Registry Moves to Next Phase

Mallinckrodt, a global biopharmaceutical company, announced that its observational registry comparing the safety and effectiveness of INOmax (nitric oxide) gas, for inhalation, in term and near-term neonates to that in preterm neonates with pulmonary hypertension (PH) was ended early due to achievement of the pre-specified primary outcome measure, non-inferiority (95 percent confidence interval: -0.0021, 0.1158, with a pre-defined margin of -0.1452). The decision was made following the second planned interim analysis at 75 percent enrollment. The company intends to share the results of this study in an appropriate scientific forum soon. INOmax is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. The safety and efficacy of INOmax in premature neonates has not been evaluated by the US Food and Drug Administration. Persistent pulmonary hypertension of the newborn (PPHN) is a serious and sometimes fatal cardiorespiratory complication of the transition to extra-uterine life. The registry trial was conducted to examine the utility of INOmax in pre-term neonates. Due to the seriousness of the condition, a randomized controlled trial cannot be conducted in the pre-term neonate population. "Mallinckrodt is extremely pleased to be able to end this registry based on positive findings much earlier than anticipated," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "The real-world data provided by this registry underscores our commitment to continue to expand upon the body of scientific knowledge on treatment of vulnerable patient populations, such as premature infants with pulmonary hypertension." The observational registry study was conducted across 31 sites and was designed to evaluate the effectiveness and safety of INOmax in 168 premature neonates vs term and near-term neonates (1:1) with PH. The interim analysis assessed 54 premature and 84 term and near-term neonates and demonstrated that the trial achieved the significance level for non-inferiority. Evaluation of significant improvement for each neonate is based on at least a 25 percent decrease in oxygenation index (OI) or surrogate OI (SOI) during the INOmax treatment period. No drug-related serious adverse events were attributed to study drug. At the time of the interim analysis, there were 17 adverse events of special interest reported in 16 subjects, most of which were in the preterm group and deemed not related or unlikely related to study drug. INOmax has been on the market in the U.S. since 2000 and is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Neonatal Intensive Care proud to add Dr Ruben Dario Restrepo to its Editorial Advisory Board

Los Angeles, CA — Health journal Neonatal Intensive Care today announced the addition of Dr Ruben Dario Restrepo to its respected Editorial Advisory Board. Dr Restrepo is Coordinator of Research Division of Respiratory Care with UT Health San Antonio, Department of Respiratory Care, San Antonio, Texas.

“We’re proud to add someone of Dr Restrepo’s caliber to the Editorial Advisory Board of Respiratory Therapy,” said Steve Goldstein, Publisher of Neonatal Intensive Care. “With the spread of COVID-19, the field of Respiratory Therapy is more important now than ever and our publication is dedicated to offering cutting-edge insight into how health-care professionals are handling this crisis. Dr Restrepo will help us achieve that mission.”
Dr Restrepo is a Fellow of the American Association of Respiratory Care (FAARC) and the American College of Chest Physicians (CHEST), a Distinguished Teaching Professor and Distinguished CHEST Educator, and has been inducted into the Kenneth I. Shine Academy of Health Science Education, and received the Regents Outstanding Teaching Award.

“I am a very passionate educator,” said Dr Restrepo. “Teaching respiratory care at a global and interprofessional level has been my motto from the time I started teaching.”

COVID-19 Global Disease Dynamics and Hands-on Treatment Best Practices

Join us on April 9 at 8 a.m. PST for an important webinar report by Pr. Luciano Gattinoni on managing critical parameters of ventilatory support for COVID-19 patients. As a researcher and a mentor to clinicians across Europe, Pr. Gattinoni has a unique, comprehensive perspective on COVID-19 care. In this webinar, he will share his observations of the disease as well as basics on how to ventilate a COVID-19 patient. A live Q&A session will follow this webinar presentation.

WHAT WILL BE COVERED
• Differences between COVID-19 and ARDS lung dynamics
• Criteria for non-invasive support versus mechanical ventilation
• Suggested ventilator settings
• The right moment to wean

WHO SHOULD ATTEND
Intensivists, ICU Clinicians, Respiratory Therapists, Respiratory Experts, Anesthesiologists, Hospitalists and Physicians and Healthcare Providers caring for COVID-19 patients.

Pr. Luciano Gattinoni is currently a Guest Professor at the University of Göttingen (Germany). He is world-renowned for inventing the “Extracorporeal CO2 Removal” technique in acute respiratory failure, promoting the “baby lung” model of lung injury (1980’s) and identified mechanical power variables to assess risks of mechanical ventilation (2016). He has previously served as President for the Italian National Society of Anesthesia and Intensive Care, the European Society of Intensive Care, and the World Federation of Societies of Intensive and Critical Care Medicine.

His research focuses on the pathophysiology and treatment of acute respiratory failure, sepsis, and acid base disorders. He has published more than 400 research articles in peer-reviewed journals. He is Honorary Member of the German Society of Anesthesiology and Intensive Care, Fellow of the Royal College of Physicians, and was awarded with the Life Time Achievement Award by the American Society of Anesthesiology, the American Society of Critical Care Medicine and the European Society of Intensive Care and the French Society of Intensive Care. Visit gehealthcare.com for more.

Two NICU Items to Remember

To keep an eye on NICU visitor temperature readings, NOVAMED USA provides an easy answer with ACCUTHERM Forehead Liquid Crystal Temperature Indicators. Simply adhere to the forehead and within 15 seconds, core body temperature is indicated. Safe for even the most sensitive skin and can be worn up to 48 hours. Not made of natural rubber latex. Offered 100 pcs/ box for $95. www.novamed-usa.com For further inquiries: Email info@novamed-usa.com. Avoid NICU out-of-stock scenarios with NEOTEMP Skin Temperature Sensors from NOVAMED USA. This reliable USA manufacturer/distributor offers a complete range of sensors to match GE/Ohmeda, Draeger/AirShields, ATOM Medical and International Biomedical incubators and radiant warmers. Call upon their neonatal specialists to assist in matching your specific requirements. For further inquiries: Email neonatal@novamed-usa.com or visit www.novamed-usa.com.

NICU Comms Tools Available

Keriton is offering 6-months of access to our patient communication tools. Learn more: www.keriton.com/special_for_nicus. Keep families connected to the NICU with realtime, HIPAA-compliant push notifications, chat and photos: Private, two-way chat between staff and families; Broadcast updates to all families with push notifications; Send families secure photos of their babies; Easy to turn-on for WOWs and desktops too.

Hy-Tape International’s COVID-19 Response

Hy-Tape International wanted to let you know what we’re doing in response to the Novel Coronavirus (COVID-19) outbreak to protect our staff and customers. We’re following federal, state, and local government health advice to make sure our customers and our colleagues stay safe and we are putting all the necessary measures in place to ensure this advice is followed by everyone. This means that we have staggered our workforce to keep our numbers lower. That being said, we appreciate your patience when placing orders. There are many steps throughout the process that may experience delays that are out of our hands. Presently we are well stocked, orders are going out on, or close to on time. Our spirits are high, we know that everyone working hard to help during these times are doing their best, and we will continue to serve our clients, answer calls, and move ahead to do our part. Thank you for your continued support and if you have any questions or concerns, please call us 1-800-248-0101.

Non-traditional means of PEEP generation utilized in conjunction with the LifePulse Jet Ventilator

Given the current COVID-19 Pandemic, hospitals may be faced with inadequate numbers of conventional ventilators due to the reallocation to other patient units. Clinicians may need to utilize non-traditional methods for PEEP and Mean Airway Pressure generation for use with the LifePulse Jet Ventilator. Recommendations are below for these optional applications. We encourage you to call the hotline at 800-800-4358 (HFJV) should this situation arise. Alarms will only be activated by the LifePulse Jet Ventilator in all of the following set up scenarios. It is essential to respond to all alarms identified on the LifePulse HFJV. Use the PEEP display on the LifePulse HFJV to monitor PEEP. The following options are only recommended to be used on stable patients, as defined by the attending physician. Filter the exhaled gas in any of the following set up scenarios. Always provide proper humidification in any of the following set up scenarios. Option One: Traditional Invasive CPAP. (Diagram 1) Provide a blended gas source to a heated wire conventional ventilator circuit. At the interface on the distal end of the expiratory limb, utilize a PEEP valve. This set up would allow for the filtration of the exhaled gases, located before the PEEP valve. In addition, this option could also utilize a T-Piece Resuscitator to function as the PEEP valve and offer intermittent positive pressure breaths given via the clinician. NOTE: The position for some PEEP valves, i.e., vertical versus inverted, will affect the PEEP value displayed on a pressure manometer. NOTE: During testing, we noticed an audible vibration when using a PEEP valve and filter together. This noise did not affect the functionality of this option. Option Two: Traditional Invasive Bubble CPAP. (Diagram 2) Provide a blended gas source to a heated wire circuit using a flowmeter. Place the distal end of the circuit in either sterile water or acetic acid bath, to generate the desired CPAP level. NOTE: Bubbles generated in the water column caused pressure fluctuations, which contributed to discrepancies between measured PEEP on the Jet and the set PEEP. Our recommendation, for this application specifically, is to use another pressure manometer for monitoring PEEP. Option Three: Utilizing a T-Piece Resuscitator. (Diagram 3) It is strongly suggested to utilize flows between 8-10 liters per minute. It is essential to heat and humidify the inspiratory gas by utilizing the manufacturer's recommended heated wire circuit. Option Four: Utilizing a T-piece circuit without the Driver. (Diagram 4) Similar to Option Three. In this option, there is a Tpiece, with a PEEP valve, placed before the humidifier to set the desired Peak Inspiratory / Pop-Off Pressure. To deliver a manual breath, the T-piece resuscitator, located on the expiratory limb near the filter, is occluded by the clinician. WARNING: Having a PEEP Valve / Pressure Pop-Off, located at the humidifier, is critical in safely applying this option. The methods described in this Bulletin are valid only for the duration of the Declared Public Health Emergency. These alternate methods of providing PEEP have not been cleared through the FDA. These methods are only to be used if a conventional ventilator is not available to provide PEEP or mean airway pressure. Although Bunnell Inc. has performed bench studies to confirm effectiveness and safety, full clinical validation with all set-ups has not been completed. If the patient is positive for Coronavirus or is suspected to be positive, we recommend the use of an expiratory filter or a traditional conventional ventilator.

St. Luke's University Health Network One of the First in the World to Pilot Masimo SafetyNet

Masimo announced that St. Luke's University Health Network (SLUHN) is one of the first institutions worldwide to use Masimo SafetyNet to monitor in-hospital patients, as the network seeks innovative solutions to care for the surge of patients infected by COVID-19. Masimo SafetyNet is an innovative, economically scalable cloud-based patient management platform designed to help clinicians care for patients remotely in hospital settings and in non-traditional settings and circumstances. The telehealth solution uses a tetherless, wearable single-patient-use sensor to monitor patients with clinically proven Masimo SET pulse oximetry, and is designed to help manage the surge in COVID-19 patients while maintaining the safety of other patients and providers, allowing hospitals to expand patient remote monitoring into alternative care spaces, including overflow locations, emergency recovery facilities, and home care settings. Aldo Carmona, MD, St. Luke's Senior Vice President of Clinical Innovation and Chairman of the Department of Anesthesia and Critical Care, said, "This technology is game-changing in light of the crush of demand on our hospitals during this COVID-19 pandemic. With this wearable device, we can create temporary, pop-up respiratory monitoring units as needed to meet the changing patient volumes and track employees' health in their homes if they have been exposed to COVID-19, the flu, or any other serious illness." Designed to track the blood oxygen saturation and respiration rate of patients who are hospitalized or quarantined at home, Masimo SafetyNet combines tetherless SET pulse oximetry with a proprietary remote data capture and surveillance platform accessible from a patient's Android or iOS smartphone or smart device. Monitoring key physiological data can help provide clinicians with an accurate snapshot of a patient's systemic health and facilitates awareness of the need for rapid execution of treatment decisions that can be life-saving. Patients are provided with a multi-day supply of single-patient-use sensors and access to the Masimo SafetyNet mobile app. With clinical feedback from St. Luke's led by Dr. Carmona and from University Hospitals led by Dr Peter Pronovost, Masimo SafetyNet has been designed for easy, intuitive use to provide customized, interactive CarePrograms that align with expert guidance on COVID-19. Monitoring data collected by the sensor is shared with the patient’s smartphone using a secure Bluetooth® connection. Twice daily, or as directed, the CareProgram can be configured to actively notify patients to answer questions such as, "are you having trouble breathing?" and "what is your temperature?", and pushes these responses along with the monitoring data to clinicians for evaluation. CarePrograms are fully customizable to accommodate each institution's protocols, each patient’s needs, and any changes in COVID-19 guidance – and can be updated through the cloud by providers even after being deployed, for maximum flexibility as situations evolve. In addition to COVID-19 CarePrograms, Masimo SafetyNet can be configured for more than 150 other CarePrograms for use with COPD, heart failure, oncology, and other patients.

On March 30, patients at St. Luke's University Health Network Bethlehem diagnosed with COVID-19 were outfitted with Masimo SafetyNet. Non-COVID-19 patients are also being monitored with this system in general medical-surgical units. St. Luke's plans to use the Masimo SafetyNet tetherless sensor and cloud-based surveillance system to monitor upwards of 2,000 hospitalized patients and lower acuity cases in the home. These may also include staff and patients who are quarantined at home with the virus. "Our patients at St. Luke’s have the most sophisticated and reliable respiratory monitoring available anywhere," Carmona says. "We know that continuous physiologic monitoring with Masimo’s Patient SafetyNet improves outcomes and saves lives. The ability to extend that capability to patients in non-traditional settings and at home during this crisis with Masimo SafetyNet is transformative. Only through our relationship with Masimo could this have been possible."

Joe Kiani, Founder and CEO of Masimo, said, "Masimo is proud to be able to work with St. Luke’s to help protect the health and safety of medical professionals and the patients they serve during this global pandemic."

Prolacta Reassures Hospitals of the Safety of Its Human Milk-Based Nutritional Products Amid COVID-19

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk-based nutritional products, notified hospital customers of the safety, quality, and continued supply of its human milk-based nutritional products. Prolacta’s products are used by neonatal intensive care units (NICUs) throughout the world to address the nutritional crisis of prematurity. “We realize these are uncertain times and there are many questions surrounding the coronavirus. We are providing hospitals with the latest scientific data needed to make informed decisions,” said Scott Elster, president and CEO of Prolacta Bioscience. “We also want to reassure these dedicated clinicians that the pandemic will not affect our commitment to supply their premature infants with life-saving nutritional products.” The US Centers for Disease Control and Prevention (CDC), the Union of European Neonatal and Perinatal Societies (UENPS), and the European Center for Disease Prevention and Control (ECDC) have all issued statements either that SARS-CoV-2 (coronavirus) does not appear to be present in breastmilk and/or that breastmilk does not appear to be a source of disease transmission. Currently, data from China show an absence of detectable coronavirus in breastmilk. Chen et al. studied lactating mothers with coronavirus. Breastmilk of six of those mothers was tested for the presence of SARS-CoV-2. The virus was not found in any of the milk specimens tested. Kam et al. looked at breastmilk from one mother with coronavirus and this testing also failed to show the presence of the virus. Prolacta exceeds all state and federal regulations for human milk quality and surpasses the quality and safety standards of all currently operating milk banks. All Prolacta products are pasteurized using time and temperature profiles defined by the US Food and Drug Administration (FDA) in its Pasteurized Milk Ordinance (PMO) to ensure destruction of pathogens. Prolacta’s pasteurization process has been independently validated using the same robust pathogen inactivation studies used in the biologics industry. This validation demonstrates that Prolacta’s pasteurization provides appropriate bacterial killing and viral inactivation including enveloped viruses. Coronavirus is an enveloped virus. Studies of other epidemic coronaviruses, such as the virus responsible for the 2003 SARS epidemic and the virus responsible for the 2012 MERS outbreak, demonstrate that pasteurization is highly effective in inactivating these viruses. These studies were done in diverse carrier media such as plasma products and various animal milks in which the virus was found during epidemic infection. Only human milk products manufactured with the FDA-defined pasteurization process, such as Prolacta’s, are clinically proven to be safe and improve health in the NICU. No published clinical data show similar results using human milk products treated by any other method. Prolacta operates the first and only pharmaceutical-grade manufacturing facilities for the testing and processing of human milk. Its two facilities have standard ISO-7 and ISO-8 cleanrooms totaling nearly 21,100 square feet. Prolacta modeled its stringent quality and safety protocols on those used in the plasma and blood industries. Prolacta has developed, validated, and implemented 19 donor milk screening tests to ensure the safety of its human milk-based nutritional products. Prolacta also has implemented the world’s first nucleic acid amplification test (NAAT) capable of directly detecting the presence of infectious disease-causing pathogens and bacteria in donated breastmilk. Since 2018, all donor milk received by Prolacta has been tested using NAAT. “All Prolacta products, including pasteurized and nutrient-standardized donor milk, are manufactured in the same manner and undergo the same quality and safety protocols,” said Elster. “We are maintaining a full inventory of finished product, as well as raw materials, and have multiple shipping partners to ensure deliveries continue as planned. Our team remains available to handle orders and any issues that arise.”

Device With Improved Oxygen Saturation Gets FDA Clearance

Device maker Masimo announced that RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry have received FDA clearance for improved oxygen saturation (SpO2) accuracy specifications for neonatal patients (<3 kg). The updated RD SET sensors’ SpO2 accuracy specifications have improved significantly, from 3% to 1.5% ARMS (at 1 standard deviation), in conditions of motion and no motion, providing clinicians with even greater confidence when monitoring the oxygenation status of neonates. With this clearance, the improved performance specifications, which were incorporated into RD SET sensors for patients >3 kg in 2018, are now available to all patient populations in the United States. Masimo’s SET pulse oximetry has been shown in more than 100 independent and objective studies to outperform other pulse oximetry technologies – even before the revisions that achieved the improved accuracy specifications – providing clinicians with increased sensitivity and specificity to help them make critical patient care decisions. Crucially for newborn health, SET has been shown to help clinicians reduce severe retinopathy of prematurity in neonates3 and in multiple studies, including the largest critical congenital heart disease (CCHD) study to date, to improve CCHD screening in newborns. In addition to offering improved accuracy, RD SET sensors are designed to enhance patient comfort, optimize clinician workflows, and help hospitals meet green initiatives. The sensors are lightweight and have a flat, soft cable with smooth edges, so that they lie comfortably on a patient’s hand or foot. In particular, RD SET NeoPt sensors with Velaid SofTouch use little to no adhesive, facilitating quick but gentle application and repositioning on the fragile skin of newborns and pre-term babies. RD SET sensors also feature an intuitive sensor-to-cable connection, while their lightweight design results in up to 84% less waste and their sleek, recyclable packaging reduces storage and shipping space. Joe Kiani, Founder and CEO of Masimo, said, “We’re delighted to announce the latest result of our continued innovation in our foundational SET pulse oximetry. We have long been dedicated to helping improve the lives of neonatal, infant, and pediatric patients, and this clearance significantly furthers that mission. Thanks to the brilliance and dedication of our engineers and the continuing support of our customers, we’ve been able to once again raise the standard for pulse oximetry performance. Even though no one has been able to create pulse oximetry that outperforms SET, we have not allowed that to stop us from continuing our pursuit of perfecting pulse oximetry.”

Nihon Kohden Launches New Ventilator System

Nihon Kohden, a US market leader in precision medical products and services, announced the launch of its new NKV-550 series ventilator system that offers a full suite of applications necessary in a critical care setting for patients of all ages – from neonate through adult. The NKV-550, introduced for the first time at the annual American Association for Respiratory Care Congress 2019 in New Orleans, is an innovative ventilator that features an integrated touchscreen, intuitive user interface, and onscreen help functions. The NKV-550 was developed to seamlessly transition between invasive ventilation, noninvasive ventilation and high-flow oxygen therapy, allowing clinicians to respond to a patient’s respiratory support needs without having to change devices. “Every product we bring to market is designed to simplify workflow for clinicians and benefit patients,” said Yasuhiro Yoshitake, president and CEO of Nihon Kohden America. “We saw a tremendous need in the respiratory market for a comprehensive ventilator that could respond to any patient situation while also providing excellent usability using modern technology.” The NKV-550 is a unique ventilator to offer Protective Control, a feature that uses a second graphic user interface placed outside the isolation room of a contagious patient who is under mechanical ventilation. The respiratory therapists and clinicians can view the ventilator monitors and alarms, adjust ventilation settings and alarm settings, and audio pause the alarm sound, through the second graphic user interface outside the isolation room, as long as the patient is within the sight of the clinician through the room’s glass window. When managing a patient who has a communicable disease case and is in isolation, this feature protects both the clinician and the patient because respiratory therapists and clinicians will not lose valuable minutes donning protective gowns, gloves and masks before responding to the needs of an infectious patient. This minimizes a potential hazard many healthcare workers face. An estimated 42 healthcare workers per million employed die each year from infections acquired at work. The NKV-550 was created based on the lung protective approach to ventilation and features the Gentle Lung suite of applications to provide clinically relevant, easy-to-use tools for the open-lung approach to ventilation. The ventilator offers highly customizable screen configurations enabling the ventilator to fit into your paradigm rather than require you adapting to it. The app-based design provides guided processes to help create a more streamlined, systematic way for clinicians to optimize care of their ventilated patients. The NKV-550 also offers on-screen help tools to walk clinicians through critical ventilator troubleshooting. Founded in Japan in 1951, Nihon Kohden is a leading manufacturer, developer and distributor of medical electronic equipment, with subsidiaries in the US, Europe and Asia. The company’s products are now used in more than 120 countries, and it is the largest supplier of electroencephalography products worldwide.

Device Gets a Hug from Company

Neotech Products announced the release of their newest product, the NeoHug Utility Device Holder. The genesis for the NeoHug came after Neotech received several similar ideas. The product design team then came together to create a device that was easy to use, useful for clinicians, and playful. “The original idea was a simple strap with suction cup and then a similar idea was submitted to Neotech. Thanks to the help of our engineering design team at Zewski Corporation, they came up with the creative animal design. After some production design challenges, we’re very excited to bring this product to market,” said Neotech President Craig McCrary. The NeoHug attaches to most smooth surfaces utilizing a large suction cup for strong hold and easy removal, while also holding under heat and humidity. The suction cup allows for repeated repositioning with no adhesive. The playful chimp design adds some color to your unit with five bright colors to choose from. The bendable arms are designed to hold a variety of lightweight items, making it ideal for holding pacifiers, suctioning tips, tape, and more. “Seeing the reaction from the clinicians has truly made developing this product worthwhile. It’s exciting to have a very functional product come to market and knowing it’s a device that can bring smiles wherever it’s being used,” McCrary said.

New Product a Solution to Meet Updated Guidelines

Neotech Products is announced the release of their newest product, the NeoHeart ECG Pad. The NeoHeart ECG Pad was designed by a clinician as a solution to meet the new NRP guidelines for neonatal resuscitation by providing an all-in-one ECG pad that can be deployed in seconds, not minutes. “In a newborn resuscitation, time is everything! What I love about the new Neotech NeoHeart ECG Pad is that with one touch you can apply all 3 ECG leads securely and out of the way so that everyone can focus on stabilizing the infant and not the equipment,” said Kathi Salley-Randall, MSN, RNC, CNS, NNP-BC. The NeoHeart ECG Pad features a 3-in-1 pre-wired electrode array and pre-measured sensor position for clinician ease of use. Its one-touch application makes it ideal for use in the delivery room. The NeoHeart ECG Pad was engineered for back application, allowing the chest to remain exposed. “As most of us know, it is extremely difficult to assess heart rate in the first critical minutes of a sick newborns life. Palpation and auscultation of heart rate in the delivery room are not accurate and more importantly take valuable time and hands away from more critical tasks. The new NeoHeart ECG Pad gives accurate heart rate readings in seconds (not minutes) so that we can quickly assess the newborn's needs and effectiveness of interventions without having to stop to check the heart rate manually,” Salley-Randall said.

Oximetry Device Cleared by the FDA

Masimo announced that O3 Regional Oximetry has received FDA clearance for use on neonatal and infant patients (<10 kg). O3 may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain. With this expansion of the O3 platform, the benefits of monitoring with O3 are now available to patients of all ages, from neonates to adults. O3, which uses near-infrared spectroscopy (NIRS) to monitor the regional hemoglobin oxygen saturation of blood (rSO2) on both sides of the brain, may be particularly helpful in providing insight into neonatal patient status because neonatal pathology is often brain-related. In neonates, O3 provides reliable measurement with a 3% ARMS trending accuracy specification.

O3 sensors are available in three sizes, for adult (≥40 kg), pediatric (≥5 kg and <40 kg) and now infant and neonatal (<10 kg) patients. With its smaller size and flexible design, the neonatal sensor is designed to fit easily and comfortably on the delicate foreheads of tiny patients. O3 is available as a Masimo Open Connect (MOC-9) module for the Root Patient Monitoring and Connectivity Platform. Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions. Root's plug-and-play expansion capabilities allow clinicians to simultaneously monitor with O3 and other measurements, such as SET Measure-through Motion and Low Perfusion pulse oximetry, providing clinicians with expanded visibility of neonatal oxygenation status. Additional modalities available on Root include advanced rainbow noninvasive measurements such as total hemoglobin (SpHb), SedLine brain function monitoring (available for adult patients), NomoLine capnography, and more – all via an easy-to-interpret, customizable display. Using Root in combination with Masimo Patient SafetyNet or Iris Gateway, monitoring data from O3 can be automatically charted in electronic medical records (EMRs).

Joe Kiani, Founder and CEO of Masimo, said, "From our inception, we have been committed to improving outcomes for the youngest and most fragile patients. Our foundational SET pulse oximetry was designed with neonates and infants in mind. These patients were not an afterthought. This focus has paid off for these young patients: SET pulse oximetry has helped clinicians reduce the incidence of severe retinopathy of prematurity (ROP) in neonates and improve critical congenital heart disease (CCHD) screening in newborns. O3 Regional Oximetry, with its ability to help clinicians accurately track cerebral oxygen saturation, will hopefully have a similar impact. We are happy to be able to bring O3's advanced capabilities and accuracy to the neonatal patient population."

NeoConnect at Home OTC Reusable ENFit Syringe Line Unveiled

NeoMed is excited to unveil NeoConnect at Home, a reusable portfolio of ENFit syringes that do not require a physician’s prescription. As a leading ENFit solution provider, NeoMed is dedicated to making it easier than ever for home patients to access the ENFit syringes they need. The NeoConnect at Home line of ENFit syringes is the first of its kind to be available over-the-counter (OTC) AND FDA 510(k) cleared for reuse. Ideal for patients in non-clinical and homecare settings, each syringe may be hand washed and reused up to 20 times by one user when cleaned per the cleaning instructions provided with the syringe. Reusability allows for a cost-effective and eco-friendly alternative to single use ENFit syringes. The syringe portfolio will be available in four convenient sizes (3 mL, 6 mL, 12 mL and 60 mL). Complete with a durable polypropylene plunger and silicone O-ring gasket, the syringes will feature clear barrels with easy-to-read black markings and will be offered in consumer-friendly case quantities. The product line will be available for purchase through retail and online stores, DME’s and homecare companies in the fall of 2019. ENFit is the registered trademark of the Global Enteral Device Supplier Association (GEDSA) and is commonly used to identify ISO 80369-3 compliant connectors. ENFit connectors help reduce the risk of enteral tube feeding misconnections and improve patient safety. GEDSA encourages manufacturers to introduce enteral devices with ENFit connectors, and healthcare facilities to adopt feeding systems with ENFit connectors as soon as possible. “The development of our NeoConnect at Home line of OTC reusable ENFit syringes is a direct result of feedback from customers concerned about ENFit syringe access and availability. Not only have we made our syringes more accessible, we’ve added value by ensuring they can be reused. It is our hope that ENFit syringe OTC availability and reusability will make enteral feeding and medication delivery hassle-free and cost-effective,” said Marc Waldman, Vice President of Business Development at NeoMed. “We are proud to be the first in the industry to offer reusable ENFit syringes that are available without a prescription. We believe that this innovation will improve ENFit device access and advance the worldwide adoption and implementation of safer enteral connectors,” remarked NeoMed President Aaron Ingram.

Newborn Hearing Screening Device Unveiled

MAICO Diagnostics, MPLS, MN, a leading global manufacturer of hearing instruments since 1937, has unveiled the easyScreen with BERAphone. “Continuing our commitment to newborn hearing screening programs, the easyScreen unites AABR, OAE, plus the patented technology of BERAphone, our no cost disposable newborn hearing screening device,” said a news release. Built on the legacy of the MAICO MB 11 BERAphone the easyScreen BERAphone allows you to perform ABR screening without the expense and waste of disposables. The reusable electrodes and ear cushion are built right into the instrument. Achieve fast test times with our technology that features the patented CE Chirp stimulus and powerful response detection algorithm. Save money; save time; help save the planet. easyScreen BERAphone® incorporates features requested by customers: Button on the BERAphone handle allows you to start, pause and stop the test right where you are, at the baby’s side; Red and Blue LEDs indicate the selected test ear to assure test accuracy; LEDs provide feedback about measurement quality during the impedance test and ABR data collection; Oval, semi-transparent ear cushion helps you see the placement around the ear and provides superior fit on small heads. The power of the unique MAICO BERAphone combined with the portability and ease-of-use of the easyScreen. An unbeatable combination.

FDA Approves Abbott’s Amplatzer Piccolo Occluder

Abbott has announced the US Food and Drug Administration (FDA) approved the Amplatzer Piccolo Occluder, the world's first medical device that can be implanted in the tiniest babies (weighing as little as two pounds) using a minimally invasive procedure to treat patent ductus arteriosus, or PDA. The Amplatzer Piccolo, a device even smaller than a small pea, now offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medical management and high risk to undergo corrective surgery. One of the most common congenital heart defects occurring in premature babies, PDA is a potentially life-threatening opening between two blood vessels leading from the heart. This channel, which is present in normally developing fetuses, is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the fetus' body. For most infants, the pathway, or duct, seals itself shortly after birth. In some cases, primarily in babies born prematurely, the PDA fails to spontaneously close, which can make it difficult for babies to breathe normally due to increased blood flow to the lungs. PDA accounts for up to 10 per cent of all congenital heart disease. Approximately 60,000 premature babies in the U.S. are born each year with a very low birth weight, and nearly 12,000 (one out of five) of these have a hemodynamically significant PDA – a PDA that is large and causes symptoms – which will require urgent treatment for the baby to survive. "This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive," said Evan Zahn, MD, director of the Congenital Heart Program at Cedars-Sinai's Smidt Heart Institute, and principal investigator for the study that led to FDA approval. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening in the heart. It is designed to allow the physician to insert it through the aortic or pulmonary artery, as well as to retrieve and redeploy the device for optimal placement. Because the device is deployed in a minimally invasive procedure, many of the premature babies who are critically ill in the neonatal intensive care unit are able to be weaned from artificial respirator support soon after the procedure. Born at 27 weeks, twin babies Irie and Judah Felkner of Columbus, Ohio, were both fighting for their lives in the neonatal intensive care unit when an echocardiogram revealed Irie had a PDA that required immediate treatment. "The doctor thought Abbott's Amplatzer Piccolo device was the best solution for Irie, and after learning more about the procedure we decided to move forward," said Crissa Felkner, Irie's mother. "You have to live it to fully appreciate what that device did for our daughter. Three days after the procedure, she was making great progress and is now a normal toddler with no limitations. The Abbott device was truly lifesaving for our daughter." The Felkner twins were treated as part of the US pivotal trial, ADO II AS, which helped to support the FDA approval of the device. The trial evaluated the Amplatzer Piccolo Occluder and enrolled 50 patients with a PDA who were older than three days at eight centers across the U.S. The safety and efficacy of the device is further supported by additional experience with the device under a continued access protocol involving 150 more patients. "Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts," said Michael Dale, vice president for Abbott's structural heart business. "Our mission is to develop life-changing technology to help people live better lives through improved health. This approval is another important step toward achieving our mission for the patients and physicians we serve." The Amplatzer Piccolo device builds on more than 20 years of clinical success for Abbott's family of Amplatzer Occluder therapies, including the Amplatzer™ Duct Occluder II product, already approved for use in the U.S., Europe and countries around the world to treat PDA in larger size pediatric patients. Abbott is committed to developing minimally invasive life-saving pediatric devices that have an immediate impact with long-term benefits, reduce the risks of life-threatening complications and allow physicians to confidently treat the youngest and tiniest patients. The FDA approval of the Amplatzer Piccolo device follows last year's approval of the world's smallest rotatable mechanical heart valve. The Masters HP 15mm pediatric mechanical heart valve provided surgeons with a much-needed option for treating vulnerable, high-risk pediatric patients with congenital heart defects and no other approved options. For US Important Safety Information about the Amplatzer Piccolo Occluder, visit https://www.structuralheartsolutions.com/us/piccolo-ISI.

Funds Approved to Fight Pathogenic Bacteria

Evolve BioSystems, Inc., the leading infant gut microbiome company, announced that it has completed a $40 million Series C round of funding co-led by the Bill & Melinda Gates Foundation, and Horizons Ventures, the venture division of the Li Ka Shing Foundation. The Gates Foundation and Horizons Ventures are joined by new investors Johnson & Johnson Innovation – JJDC, Inc., Arla Foods, and Continental Grain Company in the Series C round of funding. In addition to these leading institutions, Evolve's loyal existing investor base, which includes Tate & Lyle Ventures, Alta Ventures, MLS Capital, Acre Ventures and Bow Capital, have all fully participated in this round. The new funds will be used to expand the availability of Evolve's flagship infant probiotic product, Evivo, in the US and worldwide. Evivo is an activated form of the beneficial bacteria Bifidobacterium longum subsp. infantis (B. infantisEVC001) and is clinically proven to restore the key beneficial bacteria to the infant gut microbiome and, thereby, reduce potentially pathogenic bacteria by 80 percent. In addition to expanding its global footprint, this new financing will also support efforts to develop new products for different age segments beyond infants, and accelerate company efforts to bring to market the first-of-its-kind microbiome diagnostic test. Evolve and the Gates Foundation will further expand their partnership, announced in April, to investigate how Evivo can help infants suffering from severe acute malnutrition (SAM) through the restoration of the gut microbiome. Severe acute malnutrition affects 16 million children worldwide, making them nine times more likely to die than well-nourished children. Through this investment, the Gates Foundation will work with Evolve to help further develop and evaluate its Evivo product and help determine the role of B. infantis - in combination with breastfeeding - in supporting the healthy growth and development of infants as well as preventing infection in developing countries. Evolve will look to expand its presence beyond North America and break into new markets where newborns are also missing B. infantis due to the unintentional consequences of C-sections, antibiotic usage, and formula feeding, which make it increasingly unlikely that today's mothers have this beneficial bacteria to pass along to their babies.

Syringe Added to Device Portfolio

NeoMed has announced it has added the 100 mL syringe to its portfolio of characterized syringes for use in the Medfusion v6 3500 Enteral Ready Pump. NeoMed’s 100 mL syringe and the Medfusion Enteral Ready Pump are designed to serve as a single solution for the higher volume nutrition delivery needs of NICU and PICU patients. With the addition of the newly characterized 100 mL syringe, NeoMed now offers 65 syringe configurations in sizes ranging from 6 mL to 100 mL for use in the Medfusion Enteral Ready Pump. The 100 mL syringe has significantly lower priming volume compared to giving sets used with bags and may help reduce the number of syringes needed to administer a single large volume feed. Furthermore, the 100 mL features an off-center tip, solid polypropylene plunger, and hands-free tip cap, designed to help maximize nutrition delivery while enhancing aseptic technique. NeoMed has partnered with Smiths Medical to provide an enteral ready pump. Once installed, the NeoMed Enteral Library can be used for both Legacy and NeoConnect syringes. This enteral pump solution adheres to the Joint Commission’s recommendation, which states, “Use distinctly different pumps for IV applications” and “Do not use IV tubing or pumps for enteral feeding.” Orange and purple faceplate options are available to color coordinate with NeoMed’s Enteral Safety System, offering visual distinction from common parenteral or IV lines. Vice President of Business Development, Marc Waldman, stated, “Optimal nutrition delivery always remains at the forefront of our product design. It is our hope that the 100 mL syringe will replace costly feeding bags that may not deliver maximum macronutrients, micronutrients, and lipids to the patients that need them most.” Vice President of Engineering and Product Development, Ben Davis, said, “We are so pleased to now offer the largest enteral syringe that is available for use with Medfusion pumps. Previously, 60 mL was the largest volume that could be administered on a Medfusion pump using a single syringe. Now, a volume of up to 100 mL can be administered with a single syringe on the same pump.”

RSV Trial Reaches Milestone

Novavax, Inc. announced it has reached a significant milestone in the Prepare Phase 3 clinical trial of its respiratory syncytial virus F protein recombinant nanoparticle vaccine (RSV F Vaccine) for infants via maternal immunization. Enrollment has reached approximately 4,600 participants — at least 3,000 have received the RSV F Vaccine. Prepare is a global, pivotal Phase 3 clinical trial of the RSV F Vaccine, in healthy, third-trimester pregnant women, which initiated in December 2015. The primary objective of the Prepare trial is to determine the efficacy of maternal immunization with the RSV F Vaccine against medically significant RSV-positive lower respiratory tract infection (LRTI) in infants through a minimum of the first 90 days of life and up through the first six months of life. “Reaching this enrollment target for the Prepare trial is a significant milestone in the advancement of our RSV F Vaccine franchise,” said Stanley C. Erck, President and CEO of Novavax, Inc. “RSV remains an urgent global unmet medical need due to the mortality and morbidity associated with RSV disease in infants and the absence of a vaccine to prevent such disease. We look forward to completing the interim analysis of the Prepare trial as this is the next step on the path to filing marketing applications in the U.S. and Europe for the first-ever RSV vaccine.” Novavax will initiate a prespecified interim efficacy analysis for the Prepare trial after the last infant born to the approximately 4,600 women enrolled in the trial has been followed for six months. Novavax expects to report on the interim data in the first quarter of 2019. Assuming successful interim analysis results, the trial would be concluded without further enrollment and Novavax would file a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) with the European Medicines Agency (EMA) by the first quarter of 2020. With Fast Track designation previously granted by the FDA, the Novavax RSV F Vaccine could potentially be eligible for priority review of the BLA, which reduces the standard FDA review by four months. In December 2017, Novavax conducted an informational analysis related to the prevention of medically significant RSV-positive LRTI in a subset of 1,300 infants from the Prepare trial. This analysis allows Novavax to conclude that the vaccine’s potential observed efficacy in this subset group is in the range of 45% and 100%. The Prepare trial is supported by a grant of up to $89.1 million from the Bill & Melinda Gates Fund. This grant supports development activities, product licensing efforts and World Health Organization prequalification of the RSV F Vaccine. RSV is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively. In the US, RSV is the leading cause of hospitalization of infants. Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common. Currently, there is no approved RSV vaccine available.

Device Promises Comfort to Secure Nasal Prongs

Baby Head Band and Circuit Bumpers from Respiralogics are intended to secure the nasal interface during oxygen therapy, nCPAP or NIV therapy. The Baby Head Band is made of breathable, non-latex foam that absorbs and wicks away moisture leaving the scalp and skin dry. The soft material of the head band allows it to conform to even the tiniest of heads while maintaining the circuit position. The soft outer covering of the Baby Head Band allows for easy head movement while holding the nasal prongs and circuit stable. The new reversible Circuit Bumpers secure and stabilize the position of the inspiratory and expiratory limbs to the soft outer side of Head Band while providing optimal positioning for infants of all shapes and sizes. The Head Band and Circuit Bumpers work in conjunction with neonatal/pediatric ventilator circuits and oxygen therapy tubing. Benefits include: fashioned to provide a comfortable fit for all infants; sized by head circumference for easy and quick application; Reversible Velcro Bumpers allow for secure attachment and minimize pressure points; allows caregivers to freely move infant without interrupting therapy; opened at the crown for fontanel checks and to accommodate scalp vein IVs; available in four sizes for very low birth weight up to 10 kg infants; Single Patient Use, non-latex material.Designed for use in NICU, PICU, surgery and clinics for stable positioning of nasal interface.

Transilluminator Introduced

Neotech Products announced the release of the NeoGlo 2.0 and the NeoGlo Sleeve. After the successful launch of the NeoGlo Transilluminator in 2017, Neotech received product input from clinicians and end users on how to make the product even better. They heard their feedback and from it came the NeoGlo 2.0 and the NeoGlo Sleeve. The NeoGlo 2.0 features a new light setting, upward facing white and red lights on at the same time. This provides the user with a fourth option to aid in the examination of soft tissue. The NeoGlo 2.0 also features three new colors: Bright Pink, Aqua, and Violet, to compliment the existing colors of Rose, Blue, Silver, Black, and White. “Neotech takes the time to listen to feedback from clinicians. This feedback births changes throughout all of our product lines. Without this valuable feedback we would not be able to advance our technology for the benefit of the user,” said Sara Dimmitt, Manager of Business Development. Along with the new NeoGlo, Neotech is releasing the NeoGlo Sleeve. The NeoGlo sleeve is a disposable, protective cover designed to help keep the NeoGlo clean and protect against bodily fluids. The NeoGlo Sleeve is durable, disposable, and features a self-sealing flap. “With infection control being a top priority in the hospital, we wanted to create something that was a quick, easy solution to add a layer of protection for the NeoGlo,” Dimmitt said.

Simpler Method for Bedside Pressure Measurement

Respiralogics’ introduces GiO 1 Digital Pressure Gauge for real time display of airway pressure. The GiO provides a simple method for bedside pressure measurement in an easy to read digital display.There are no complicated buttons or display screens with the GiO. Start with two buttons and unlock the possibilities.The GiO Digital Pressure Gauge can be used in a wide range of applications and clinical settings. GiO is backlit for ease of reading in minimal light environments. Battery operated; GiO has an auto power off feature to extend the life of the lithium battery. GiO 1, with pressure measurement between 0 to 30 cmH2O, is specifically designed for both non-invasive and invasive infant/neonatal applications. Portable and compact, GiO can conveniently accomplish your pressure monitoring needs at the bedside as well during transport. The GiO Pressure Gauge is packaged complete with hydrophobic filters, pressure line, elbow connectors and straight leur connector. Individual patient pressure line and replacement filter kits are available for bedside use. The GiO Pressure Gauge is available in different pressure ranges for large pediatric and adult applications. Visit www.respiralogics.com for all Respiralogics products and information.

Device to Help Neonates With Dosing Difficulties

NeoMed announced the launch of the new NeoConnect DoseMate DL (Directional Long) – an innovative and ergonomic solution for gentle, direct oral medication administration with an ENFit syringe. This new, patent-pending pharmacy accessory is ideal for dosing oral medications directly to the patient’s cheek or back of the mouth. The soft, pliable cannula features a smooth, rounded tip, which is optimal when administering oral medication into a patient’s mouth. Not only does the inventive design mitigate concerns over placing threaded syringe tips into a patient’s mouth, it also provides patient comfort during direct oral administration without introducing a choking hazard. Dosing accuracy is a key component of the DoseMate DL design. Similar to its DoseMate counterpart, the DoseMate DL minimizes priming volume and helps prevent fluid accumulation in the syringe’s moat, which complies with the Global Enteral Device Supplier Association’s (GEDSA) August 2016 position statement. Ben Davis, Vice President of Engineering and Product Development, said, “Not only does the DoseMate DL satisfy a clinical need not previously addressed with other ENFit systems, but it also represents an improvement in care compared to what was available with legacy systems.” “The addition of the DoseMate DL to our ENFit accessories portfolio contributes to our mission of supporting the specialized feeding and medication dosing needs of the low birth weight, neonatal, and pediatric patient populations. We are very pleased to release a new product focused on patient comfort, while following clinical best practices. The DoseMate DL is yet another effective accessory that will help minimize protocol changes for clinicians as the global transition to ENFit continues,” stated NeoMed President, Aaron Ingram. For ordering information, contact your local sales representative, visit www.neomedinc.com, or call 888-876-2225.

Generational Loss of Good Bacteria in Baby's Gut Microbiome

Evolve BioSystems announced new research that connects elevated infant fecal pH levels to a profound change in the infant gut microbiome, including the disappearance of a beneficial bacterium that may be key to short and long-term health. Over the past 100 years, the average pH level of a baby's stool, which can indicate the type of bacteria in the baby's gut, has undergone an alarming increase from pH 5.0 to 6.5. The study, published in the American Society for Microbiology journal mSphere, connects this rise in pH to a generational loss of Bifidobacterium, a critical gut bacteria during infancy, and an accompanying increase in a number of harmful bacteria. The complete study is called Elevated Fecal pH Indicates a Profound Change in the Breastfed Infant Gut Microbiome Due to Reduction of Bifidobacterium over the Past Century. A review of 14 clinical studies published between 1926 and 2017, representing hundreds of healthy breastfed infants, showed a change in fecal pH from 5.0 to 6.5 over this time period. The authors attribute this trend to an observed reduction of Bifidobacterium in the infant gut, along with an increase in potentially harmful bacteria such as E. coli and Clostridia, resulting in "dysbiosis," a potentially detrimental imbalance of the gut microbial ecosystem. According to study co-author, Dr Jennifer Smilowitz, Associate Director of the Human Studies Research Program for the Foods for Health Institute at UC Davis, "These alarming changes to the infant gut microbiome and thus, gut environment, may be due to modern medical practices like antibiotics, C-sections, and formula feeding. These are all potentially life-saving medical practices, but have unintended consequences on the infant gut microbiome. As a result, certain pathogenic bacteria—those linked to higher risk of health issues such as colic, eczema, allergies, diabetes and obesity—thrive. The need for clinicians to have a quick and reliable method to determine Bifidobacterium levels in baby's gut, and an effective way to replace the right Bifidobacterium to correct dysbiosis when detected, are the critical next steps for infant health." In December 2017, Evolve BioSystems published results of a landmark clinical trial in mSphere, showing that Evivo, an activated form of B. infantis, produced rapid, substantial, and persistent improvements in the gut microbiome of breastfed infants. Evivo is the only baby probiotic clinically proven to restore the levels of Bifidobacterium to baby's gut, reduce potentially harmful gut bacteria by 80 percent, and return fecal pH to levels seen historically. For more information about Evivo, please visit www.evivo.com.

Restoring a Baby’s Gut Microbiome

Evolve BioSystems, Inc. announced a first-to-market, single-use liquid form of Evivo (activated B. infantis EVC001, ActiBif). Evivo with MCT Oil, the first and only probiotic clinically proven to work with breast milk to restore a baby's gut microbiome to its natural state, is now available as single use administration for infants in a hospital setting. Research indicates that B. infantis may be both restorative and protective in the infant gut. Administering Evivo with breast milk is clinically proven to allow B. infantis to thrive and dominate the infant gut microbiome while also reducing relative populations of potentially harmful bacteria, such as E. coli, clostridia, Staphylococcus (Staph), and Streptococcus (Strep). A healthy gut microbiome at birth paves the way for lifelong health. Modern medical practices such as C-sections, antibiotic use and formula feeding along with environmental factors in the hospital can impact the development of the infant microbiome. Research has shown that administration of probiotics to infants in the hospital is safe and effective, and may reduce the incidence of many serious, and sometimes devastating conditions. Probiotic administration has also been linked to shorter time to full feeds and may reduce incidence of sepsis. "Safety and consistent high quality are crucial in the NICU environment," said Thomas Young, MD, neonatologist and former NICU director and Mother's Milk Bank medical director at WakeMed in Raleigh, North Carolina. "Evivo with MCT Oil, as a single-use liquid product, will be preferable to probiotics in powder form or multiuse packaging. This formulation allows for administration to term infants in the NICU and is an essential step toward properly designed clinical trials in neonates going forward." In this formulation, Evivo's beneficial bacteria are mixed with medium chain triglyceride oil (MCT oil), providing a safe and streamlined way to deliver the probiotic to infants in a hospital setting. Evivo helps protect the baby's gut microbiome through a variety of actions derived from its ability to consume human milk oligosaccharides (HMOs). The beneficial bacteria in Evivo are able to utilize the HMOs in breast milk in a unique and superior manner compared to other gut bacteria, and convert HMOs into nutrients that nourish both the infant and the gut microbiome. The bacteria in Evivo have been shown to be anti-inflammatory, to decrease intestinal permeability, and increase the production of lactate and acetate, which can suppress the growth of potentially harmful bacteria. Furthermore, Evivo given daily to breastfed infants was shown to result in significantly fewer loose and watery stools per day, without an increase in incidence of jaundice or other adverse events. Evolve BioSystems' landmark clinical trial, recently published in the American Society for Microbiology journal mSphere, showed that providing dietary B. infantis EVC001 resulted in rapid, substantial, and persistent remodeling of the gut microbiome in breastfed infants. This stable colonization of B. infantis EVC001 led to significant reduction in the abundance of potentially harmful bacteria. In addition, this improved gut profile persisted for more than 30 days after dietary B. infantis was discontinued, as long as infants continued to consume breast milk.

Benefits Found in Probiotic Bacteria

Evolve BioSystems, Inc. announced positive results from their landmark clinical trial in support of Evivo, an activated form of the beneficial bacteria Bifidobacterium longum subsp. Infantis (B. infantis EVC001, ActiBif). The study showed that providing dietary B. infantis EVC001 resulted in rapid, substantial, and persistent remodeling of the gut microbiome in breastfed infants. This stable colonization of B. infantis EVC001 led to significant reduction in the abundance of potentially harmful bacteria. In addition, this improved gut profile persisted for more than 30 days after dietary B. infantis was discontinued, as long as infants continued to consume breast milk. The findings from the IMPRINT (Infant Microbiome Probiotic Intake Trial) clinical trial were published this week in the American Society for Microbiology journal mSphere. Historically, bifidobacteria, particularly B. infantis, created a protective microbial environment by dominating the infant gut, and continue to do so today in many developing countries. However, modern medical practices such as antibiotic use and C-section deliveries have led to the near-total loss of this keystone gut microbe in infants in developed countries, creating widespread gut dysbiosis. A dysbiotic gut microbiome during infancy has been associated with the growing pandemic of chronic health issues including allergies, asthma, obesity, and type 1 diabetes. To date, no other clinical study has demonstrated a substantial change in the gut microbiome via probiotic use. "These results with B. infantis EVC001 demonstrate for the first time that when the appropriate probiotic bacteria is provided in combination with breast milk, it can rapidly and stably colonize the infant gut microbiome while significantly reducing levels of potentially harmful bacteria linked to long-term disease," said Mark Underwood MAS, MD, Chief of Pediatric Neonatology and Professor of Pediatrics at the University of California Davis and a principle investigator on the study. "This study is extremely important for infant health and nutrition because we may now have the potential to impact many common health issues by simply restoring the microbiome to its natural state. The IMPRINT study showed that breastfed infants who received the probiotic achieved a 79% increase in levels of Bifidobacteria, as measured in stool samples and subsequently confirmed to be B. infantis EVC001. Additionally, these infants experienced an 80% reduction of potentially harmful bacteria like Clostridium and E. coli, which have been linked to chronic diseases later in life. The study also demonstrated that infants colonized at high levels by bifidobacteria, including B. infantis EVC001, had significantly lower levels of endotoxin, a known trigger of inflammation. The IMPRINT results further confirmed the unique mechanism of action of B. infantis EVC001, showing it maintained its dominant position in the infant microbiome as a result of its unique ability to consume certain components of human milk (human milk oligosaccharides; HMOs) that are otherwise unused by the infant. The IMPRINT trial was a parallel, controlled clinical study in exclusively breastfed infants, that included 68 mother-infant pairs who received either lactation support plus B. infantis EVC001 or lactation support alone. Infants randomized to the probiotic group received one daily serving of B. infantis EVC001 for 21 consecutive days starting on day seven after birth and continued through day 27. The study design, as well as safety and tolerability results were previously published by Smilowitz et al in BMC Pediatrics (2017).

Infant Hearing Screening Device Unveiled

MAICO Diagnostics, MPLS, MN, leading global manufacturer of hearing screening instruments, since 1937, introduces the easyScreen. Continuing our commitment to newborn hearing screening programs, the easyScreen unites AABR and OAE screening capabilities in one device for the first time in MAICO history. Newborn hearing screening has never been so easy. Perfect for the use in hospital well-baby units, the NICU or in the follow-up clinic, easyScreen is designed to lighten your daily workload. It fits right into your pocket, is lightweight and will get you accurate results within seconds. The resistive 4.3" touchscreen works with medical gloves and allows you to start a test with only 3 clicks. easyScreen is fast, easy to handle and comes with on-screen guidance. Even first-time users will confidently achieve the most accurate results with the help of easyScreen. easyScreen makes use of the CE-Chirp stimulus and a powerful detection algorithm. Together, they achieve accurate pass and refer results within seconds. The patented CE-Chirp stimulates all regions of the cochlea at the same time and thus generates a much larger response – for faster results than a standard click. The easyScreen is supported by a dedicated HearSIM software that is just as intuitive to use as the easyScreen. Using HearSIM you can store, view and manage patient and screening data on your PC. For further information, visit the MAICO's website, www.maico-diagnostics.com.

Unique Holder Adapts to Neonatal & Small Pediatric Circuits

Respiralogics, a provider of innovative products for hospital, emergency, home and specialty care, has announced its NeoTree Tube Support. NeoTree Tube Support works in conjunction with neonatal and pediatric ventilator circuits. NeoTree Tube Support is reversible in position to accommodate ventilator circuits and tubings. It is constructed of lightweight aluminum with a baked-on power coat finish. The tube holder is reusable, durable and easily cleaned. NeoTree Tube Support provides a stable holder for tubes in all positions. NeoTree Tube Support assists in the reduction of tension on the endotracheal tube or face mask to prevent kinking of the circuit, inadvertent extubations and/or movement of the endotracheal tube or mask in NICU, PICU, Surgery and Clinic settings. More information can be found at www.respiralogics.com.

Handheld Exam Light Unveiled

Device maker Sylvan Corporation has unveiled its Neoscan® LED transilluminator, a handheld exam light that offers a brilliant white light output for excellent contrast between tissues, veins, and organs. With a simple push-button on/off switch and a silicone encased four-foot fiberoptic cable, this transilluminator is designed for easy operation. The all-aluminum body, LED lamp, and rubber switch cover makes this water-resistant, drop resistant, and built to endure the rigorous daily use of the hospital environment. With the brightest light output offered by Sylvan Corporation, the Neoscan® LED transilluminator helps healthcare professionals discover the contrast between muscle tissues, internal organs, and veins in a variety of patients. Made in the US.

New Mask Conforms to Infants' Faces

Respiralogics' announces the US release of the Babi.Plus nMask precisely designed to easily conform to an infant's face, facilitating a good seal for optimal ventilation during resuscitation and non-invasive support. The soft, brushed silicone material minimizes skin irritation. The circular design of the nMask provides a comfortable anatomical seal for the very low birth weight infants through toddlers. The clear nMask provides a good view of the patient/mask interface to ensure proper fit and size. The Babi.Plus nMask is offered in 6 sizes to accommodate the ELBW infant through small pediatric patient. Integral 15mm connector with two level barb design at the inlet of the nMask allows for easier attachment and better fixation. Available in 25mm, 30 mm, 35 mm, 40 mm, 45 mm and 50 mm masks; each nMask is individually packaged and ready for use with resuscitation bag or t-piece resuscitator system. The Babi.Plus nMask can be used in all neonatal critical care units, delivery rooms, pediatric critical care units and special procedure units. Respiralogics specializes in providing tools to meet the unique needs of respiratory patients. We listen to our customers and use that knowledge to assist in development and support of specialty products to benefit patients and clinicians. We have joined with leading specialty respiratory distributors across the USA to provide expert local assistance and the training required for successful implementation. For more information on the Babi.Plus nMask and all Respiralogics products go to www.respiralogics.com

Let There Be Light On Patients

Neotech Products has announced the release of their newest product, the NeoGlo Transilluminator. The NeoGlo Transilluminator is a light source that transmits light through tissues to aid in the examination of patients. It is used to find veins, arteries, and other internal structures. This innovative vein finder features LED lights that are cool to the touch for patient safety. It has multiple light settings for user preference including forward facing white lights, upward facing white lights, and upward facing red lights. It's compact size and ergonomic design was engineered with clinician comfort in mind. The NeoGlo is available in five colors, blue, rose, white, silver, and black. It is powered by a single AA battery and is engineered to shut off before the lights become ineffective. "We like to say 'designed with the clinician in mind,'" said Neotech Products President, Craig McCrary. "The truth is, clinical input was key to the development. A doctor presented his original idea to Neotech two years ago. Respiratory Therapists and Registered Nurses then added their input. They told us what they'd like to see in a transilluminator. Next, our engineers showed us what they could do. And together, we developed the NeoGlo into an exceptional and innovative vein finder. "Our mold makers also offered input," McCrary continues. "Before going to production, we modified the mold to add the lanyard clip. Which is a simple feature that adds value for the clinicians. No other single device offers the features we do for the price; under $100. Plus the NeoGlo is made in USA."

Save the Date For These Fall 2017 Bubble CPAP Conferences

These unique programs will share successful bubble nasal CPAP experience, discuss rationale, plus practical aspects and strategies for replicating success with bubble CPAP use. The conferences are intended for the entire neonatal critical care team and other allied health professionals in the neonatal intensive care arena. The 27th Annual Course Respiratory Care of the Newborn — A Practical Approach is on October 7-8, 2017 in New York, NY. Learn more at www.ColumbiaCME.org. And the 7th Annual Bubble CPAP and Non-Invasive Respiratory Management of the Newborn Conference runs December 9-10, 2017 in Washington, DC. Learn more at www.bubblecpap.org.

High Frequency Ventilator Unveiled

Bunnell Incorporated has announced the upcoming release of the new LifePulse High Frequency Ventilator - Model 204! Since 1988, the Life Pulse HFJV has been used for treating premature babies in acute respiratory failure in hospitals in the U.S. and Canada. Bunnell continues a tradition of providing proven, unique High-Frequency Jet Ventilation technology in the new Model 204 LifePulse for the treatment of critically ill infants with ventilator-induced lung injuries. The new LifePulse, also known as the "Jet" ventilator, features many upgrades and benefits. More information can be found at www.bunl.com. The Model 204 LifePulse will be available for distribution beginning in September. Health Canada approval is pending. As a committed partner in effective and quality healthcare, Bunnell offers free trials, training and education, and industry-leading customer support including 24/7- hotline support at 800-800-4358.

Getinge Unifies its Brands

Getinge has announced that it has unified all its current brands under the single brand of Getinge to better convey its customer offering. As part of this new brand structure, the company has rolled out a new brand identity, which all its products will carry in the future. The rapid growth of what was previously known as Getinge Group over the last 25 years, primarily through acquisitions, has resulted in an extensive brand portfolio, including ArjoHuntleigh, Maquet, Lancer, Atrium and others. "In line with our ongoing transformation to make our company even more customer-centric, we have taken the next step of unifying all of our brands under the single brand of Getinge. This new brand structure will further strengthen our position as a leading global medtech company. Some of these brands, such as Maquet, will become product family names under the Getinge master brand," said Raoul Quintero, President of the Americas at Getinge. "As a single-brand company, we will also be better able to convey our full customer offering, which is designed to help healthcare institutions address the challenges they face in today's ever-changing healthcare environment of expanding healthcare reform initiatives, financial pressures and accelerated hospital consolidation." As healthcare institutions are being challenged to provide quality care in a leaner, more efficient manner, they are seeking partners who deliver smart, cost-saving solutions that maintain the highest standards in clinical excellence. Getinge has refocused its resources to develop and deliver more innovative healthcare solutions that will address its customers' most complex healthcare challenges and ultimately improve the daily lives of patients.

Lifeport Adapter Unveiled

Bunnell Incorporated has announced the US release of the 3.0 mm I.D. LifePort ET tube adapter for use with the Life Pulse High‐Frequency Jet Ventilator. The LifePort adapter is the connector that replaces a standard endotracheal tube adapter and allows the Life Pulse HFJV and conventional ventilator to be used in tandem. Since 1988 the Life Pulse HFJV has been used for treating premature infants in acute respiratory failure in hospitals in the US, Canada, and several other countries. The 3.0 mm LifePorts are available in boxes of 10/each. The adapters will also be included in the HFJV Breathing Circuit Kits beginning May 1, 2017. Adapters are available in 2.5, 3.0, 3.5, 4.5 and 5.5 mm sizes. For more information go to www.bunl.com.

Advanced Neonatal Ventilation During MRI Procedures 

After successful 510(k) clearance for the Neonatal option, the HAMILTON-MR1 is now available to provide sophisticated ventilation therapy during MRI procedures for even the smallest patients. With the new Neonatal option for the HAMILTON-MR1 ventilator, you can take neonatal patients from the ICU to the MRI suite and back without having to change anything about the ventilation. These seamless transfers reduce the risk of derecruitment or other setbacks, which may result in a longer hospital stay and more discomfort for your most fragile patients. The Neonatal option optimizes the HAMILTON-MR1 for MR-Conditional neonatal ventilation. With tidal volumes as low as 2 ml, the device is designed for safe, effective, and lung-protective ventilation of your smallest patients. The intelligent leak compensation function IntelliTrig automatically adjusts the inspiratory and expiratory trigger sensitivity to potential leaks. This ensures adaptive synchronization with the neonate's breathing pattern. (Variante: This enables improved synchronization with the neonate's breathing pattern.) The compact and robust housing, an integrated high-performance turbine, and powerful internal batteries make the HAMILTON-MR1 well-equipped for patient transport and easy to handle for the caregiver. The wide range of modern and classic ventilation modes allows you to offer all your patients, from neonates to adults, the same high level of ventilation care as at the bedside, whether before, during, or after the MRI procedure. The HAMILTON-MR1 is the first ventilator able to be used at a magnetic field strength of 50 mT, equivalent to 1 m distance for a 3T static magnetic field scanner, without creating any MR image artifacts. Positioning a medical device too close to the MRI scanner can have fatal consequences. For maximum safety, the HAMILTON-MR1 continuously monitors the magnetic field with TeslaSpy, an integrated gaussmeter, and gives you an audible and visual signal if you are getting too close. 

Mercury Medical Expands Team

Mercury Enterprises has announced that John Gargaro MD has joined the Corporate Board of Directors and Douglas Smith has joined the company as Vice President of Sales and Marketing. Dr. Gargaro is currently a board certified orthopedic surgeon and graduate of Harvard University and the University of Michigan Medical School. He is currently Chief of the Department of Orthopedic Surgery at Kaiser Permanente Colorado, former Chairman of the Department of Orthopedic Surgery and former Treasurer of the Medical staff at St Joseph Hospital, Denver CO. Industry experience includes consulting positions with Wright Medical and Johnson & Johnson/DePuy, as well as clinical research and speaker panel positions for Sanofi-Synthelabo Inc. and Organon Labs.

Douglas Smith's background includes 20+ years of sales and marketing experience with GE Healthcare, Dräger, Maquet Medical Systems USA and Siemens Medical Solutions USA, Inc. Mercury Medical, a veteran-owned medical products manufacturing and marketing organization, focused on airway management and anesthesia, is recognized by the industry as a leading provider of innovative airway management devices.

Firm Certified as a Veteran-Owned Business

Mercury Enterprises, Inc., dba Mercury Medical, Clearwater, Florida is verified and certified as a Veteran Owned Small Business (VOSB) by the U.S Department of Veteran Affairs, Center for Verification and Evaluation. Mercury Medical is a healthcare specialty organization recognized by the industry since 1963 as a leading provider of innovative airway management devices. As a Veteran Owned Small Business, Mercury Medical is included in the Veteran business database at www.vip.vetbiz.gov and eligible to participate in Veterans First Contracting Programs with the VA. For more information contact Mercury at www.mercurymed.com or contact by phone at 800-237-6418.

Feeding Device Determines Tongue Movement

Atlanta-based NFANT Labs LLC has announced FDA clearance for its nfant Feeding Solution. Unlike an ordinary baby bottle, nfant Feeding Solution is the only medical device that can determine an infant's tongue movement during actual feeding and provide objective, measurable data. Information is then relayed to caregivers through a mobile app and stored in a cloud database. The solution is the first Internet of Things (IoT) medical device focused on babies in the 1,100 Neonatal Intensive Care Units (NICUs) across the United States. Currently, deciding exactly when it is safe to begin oral feeding and determining how to best advance an infant's feeding is based on a caregiver's professional experience and trial and error. Now, health-care teams can use the data from nfant Feeding Solution to help determine when NICU infants are ready to transition from tube feeding to bottle or breast feeding. Each nfant Feeding Solution consists of a disposable nfant Coupling that connects the bottle to the nipple. Reusable nfant Sensors then connect to the Coupling and non-invasively measure the baby's tongue movement while transmitting that data to a smart device for display in real-time. Data is then stored in a cloud database for analysis and retrieval. In addition to real-time analytics, physicians and caregivers can also view an infant's historical feeding analytics to determine progress. NFANT Labs will start providing NICUs with nfant Feeding Solution this quarter with plans to expand its market in 2016. For more information, visit http://www.nfant.com

New Clinical Data Published on Detecting Hemolysis

Capnia, Inc. has announced a paper, titled Measuring End‐Tidal Carbon Monoxide of Jaundiced Neonates in the Birth Hospital to Identify Those with Hemolysis, has been published in Neonatology. This peer‐reviewed paper, which is expected to appear in the January 2016 print issue discusses recent clinical research demonstrating the superiority of CoSense End‐Tidal Carbon Monoxide (ETCO) Monitor at detecting hemolysis in jaundiced newborns. The results of the study conducted in neonates with bilirubin above the 75th percentile show that CoSense is more effective at identifying hemolysis than traditional measures, such as the Coombs test. Of the 100 high‐risk neonates studied at three hospitalsin the Intermountain Healthcare System, CoSense showed evidence of hemolysis in 37%, while Coombs testing showed several false negative results. None of the neonates studied with CoSense were readmitted to the hospital. In the same period of time, approximately 3% of the 3,535 neonates on whom CoSense was not used prior to discharge from the hospital, were readmitted for jaundice. The full publication can be accessed online.

Ventilation Device Addresses Transporting Neonates

The HAMILTON-T1 with neonatal option is a high-end transport ventilator that provides the best possible ventilation therapy for your smallest and most vulnerable patients. During transport, the HAMILTON-T1 delivers the same performance as a fully featured NICU ventilator at the bedside. Its unique features make it one of the best transport ventilators for neonates. Hamilton Medical has specially adapted the HAMILTON-T1 hardware and software to optimally meet the needs of ventilated neonates. Supporting tidal volumes of just 2 ml, the HAMILTON-T1 allows for effective, safe, and lung- protective ventilation for even the smallest preemies. The reliable and robust neonatal flow sensor accurately measures pressure, volume, and flow proximal to the patient. This guarantees the required sensitivity and response time, and prevents dead space ventilation. Therefore, the patient is better synchronized and the work of breathing (WOB) is reduced. The new neonatal expiratory valve can balance even the smallest differences in pressure and offers the neonate the possibility to breathe spontaneously in each phase of a controlled breathing cycle. In addition to all modern neonatal ventilation modes, the HAMILTON-T1 offers a new generation of nCPAP. In the new nCPAP-PC (pressure control) mode, you only define the desired CPAP target value for your patient and the ventilator automatically and continuously adapts the required flow to the patient's condition and possible leaks. Thanks to the demand flow technology, your patient will receive only as much flow as is necessary to obtain the set CPAP target. This reduces WOB, reduces the need for user interventions and ensures optimal leak compensation. You will also require less oxygen for transport and noise caused by the ventilator decreases distinctively. With approvals and certificates for most types of transport and situations the HAMILTON-T1 is an ideal escort for your tiniest patients, reliable everywhere, both inside and outside the hospital, in the air as well as on the ground. The built-in high-performance turbine makes it completely independent of compressed air, gas cylinders or compressors. This saves weight and space and even noninvasively ventilated neonates can be transported over long distances. The combination of a built-in and an optional hot-swappable battery provides a battery operation of more than 9 hours. This can be extended indefinitely with additional hot-swappable batteries.

Ventilator Circuit Stabilizer Launched

As many ventilator patients have become more mobile, both in long-term care centers and at home, increased safety has become an issue. One of the areas that is most important is to secure the patients ventilator circuitry and prevent accidental dislodgement.  A more mobile patient, moving from bed to wheelchair and through everyday life,  presents a unique challenge in not only providing proper ventilation but also in providing a safe method in securing the life sustaining ventilator tubing.  In these critical moments of movement, the tubing and circuitry may easily find itself ensnared in bed sheets, on wheelchair railings or other hazards, which can result in serious injury or death from ventilator disconnections. Pepper Medical has introduced two products that will eliminate this issue and provide a safer environment for these patients. The first is the 701VCS (ventilator circuit stabilizer). The 701VCS is a harness style belt made of soft cotton laminate that fits comfortably around a patient's waist. Incorporated into the harness is a tubing securement strap that reliably secures the ventilator tubing getting it out of harms way and positioned close the patient's chest. The second product is the 701VCS/NG offering the same circuitry securement but also adds a second strap used to secure a nasal gastric (or oral gastric) tube keeping it secure and avoiding decannulation thereby reducing these difficult reinsertions. Find out more at www.peppermedical.com.

Warmer Cleared by FDA

Creche Innovations has announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for the Penguin In-Line Enteral Warmer, which is intended to maintain the body temperature of breast milk that is fed enterally over extended periods of time. This addition to the Penguin line of warmers provides caregivers a solution that now assures 100% of all feedings will be easily and safely administered at "mom's temperature". The proprietary low heat technology utilized in the Penguin assures the entire nutritional value is delivered with every feeding. More importantly, the Penguin protects the babies from unwanted chemical transfers that are potentially leached into the feedings when exposed to high heat environments currently offered by competitive solutions. Unlike current enteral warmers, the Penguin In-Line Warmer is the only warmer that supports universal compatibility and is interchangeable with ALL brands of feeding pumps, extension sets, and accessories. The company plans on making the Penguin In-Line Warmer commercially available in the United States prior to the fourth quarter of 2015.

Enteral Syringes Cleared

NeoMed, Inc., which makes neonatal nutrition/enteral safety devices, announced that it received FDA 510(K) clearance from the United States Food and Drug Administration (FDA) for its NeoConnect Enteral Syringes with ENFit connector (K143344) on April 8, 2015. NeoMed is currently one of only two enteral syringe manufacturers that have received FDA 510(K) clearance for enteral syringes with ENFit connectors. The NeoConnect syringes are an important part of the NeoMed solutions for the ISO 80369-3 (ENFit) Small Bore Connector Standard, being implemented to help reduce the risk of tubing misconnections and improve patient safety. NeoMed designed the first comprehensive enteral safety system to comply with the recommendations of the Joint Commission, FDA, ASPEN, and AAMI to help prevent tubing misconnections and is proud to support the ENFit initiative. Aaron Ingram, President of NeoMed, Inc. says, "Our commitment to our customers is our continual participation with GEDSA, the trade association created to help introduce the new standards. We will continue our support of the new ISO 80369-3 standard through implementation, practice, and beyond."

Jaundice Meter Introduced

Dräger has announced the release of its next-generation Jaundice Meter – the JM-105, a non-invasive bilirubinometer that provides fast, accurate, cost-effective and pain-free jaundice screenings for newborns. JM-105 can be used on children as young as 35-weeks' gestational age. According to the Centers for Disease Control and Prevention, approximately 60 percent of full-term infants will develop jaundice within a few days of birth. While it is relatively common, jaundice is a serious issue that can lead to permanent brain damage if not treated. Traditionally, hospitals would use visual screenings and painful heel-stick blood tests to determine whether a newborn has jaundice. Not only were these processes far from accurate, but they would cause a lot of anxiety for parents and discomfort to newborns. The rise of non-invasive transcutaneous bilirubin testing (TcB) changed the way hospitals identified at-risk infants. Dräger's new JM-105 is one of the most advanced transcutaneous monitoring products available, measuring the yellowness of subcutaneous tissue in newborns as young as 35-weeks' gestational age. Providing instantaneous screening of bilirubin results, JM-105 also reduces the risk of infections: JM-105 is non-invasive; its sensor is gently pressed to a newborn infant's forehead while in a hospital; alternatively for babies 14 days of age at physician offices, measurements can be taken from the breastbone to obtain a bilirubin reading. Without the need to draw blood, the JM-105 can help to reduce the risk of infection. It also lessens readmission and length of stays: Bilirubin levels typically peak two-to-four days after birth – after most newborns have gone home. Due to this, jaundiced children are often readmitted for treatment. JM-105 detects at-risk newborns well before they leave the hospital, ensuring immediate treatment and, ultimately, reducing readmission and length-of-stay rates. Eliminates human error: Nurses or physicians can scan, measure, save and transfer patient data right from the device – eliminating time-consuming, manual transcription that often leads to human error. Enables faster decision-making: With quick access to patient data in one place, physicians and nurses can make faster treatment decisions based on accurate, timely information. Creates cost-effective testing practices: JM-105 reduces the frequency of costly lab tests and because it has a reusable probe, it eliminates the need for expensive disposables.

Milk Donor Website Launched

Medolac Laboratories, an Oregon-based human milk nutritionals start-up, has announced the launch of Donormilk.com, the first direct-to-consumer offering of human milk. Medolac’s Co-op Donor Milk human milk is commercially sterile, safe, tested, homogenized, and can be stored at room temperature making it easier for home use. In addition, Medolac human donor milk is less expensive and safer than donor milk bought from online classifieds and other milk banks where testing, safety and nutritional content cannot always be verified. This new product will make it possible for more babies to receive 100% human milk protein instead of bovine or soy protein formula. Medolac is committed to the fundamental principle that all babies should have access to breast milk and that direct breastfeeding by mothers is best for infants wherever and whenever possible. “The simple fact is that babies are healthier when they are fed human milk,” said Elena Medo, chairman and CEO of Medolac Laboratories. “Our vision at Medolac was to create a way to make human donor milk that is as easy to use as formula available for use with infants who otherwise would likely not have access to the benefits of human milk. These include babies of surrogates and non-traditional families, mothers experiencing a temporary supply shortage as well as post-discharge infants who fail to thrive on formula. With the introduction of donormilk.com, parents of healthy babies, preterm babies and medically fragile babies have access to a safe human donor milk alternative for their infants.” Because the Medolac human donor milk has been through the Medolac process, it is safe, sterile, can be stored at room temperature for up to three years and is available in a ready-to-use format. Parents who would like to provide their infants with human milk can order by visiting Donormilk.com. Parents should plan to supply a note from the infant’s primary healthcare provider to ensure the baby is under the care of a medical professional. No prescription is required and a template is available for the note on the website. For more information or to order commercially sterile, safe human donor milk, visit at donormilk.com.

FDA clears Invictus Medical's GELShield for market launch

Invictus Medical, the San Antonio, Texas-based medical device company, has received Food and Drug Administration (FDA) clearance to begin marketing its GELShield extracranial pressure relief device. The FDA cleared the GELShield with an indication to alleviate extracranial pressure due to prolonged immobility. The device has undergone a comprehensive safety validation study at the nationally recognized Baylor University Medical Center in Dallas. The center oversees approximately 4,200 births annually and operates an 83-bed, level III neonatal intensive care unit (NICU) providing the highest level of care for small and fragile newborn babies. Long-term, Invictus Medical's technology interest focuses on combating deformational plagiocephaly (DP), a cranial deformity exhibited in infants resulting from repeated external pressure to one area of the head. Studies have found a significant rise in the incidence of plagiocephaly since the early 1990s. In addition to being a cosmetic issue, DP has been associated with heightened risk for developmental delays in infants and toddlers, according to a study published in Pediatrics in 2013. To date, Invictus Medical has successfully raised $5 million. The company is in the process of securing an additional $4.5 million in Series B funding to support the commercialization efforts of the GELShield.

Rapid Whole-Genome Sequencing In Critically Ill Infants

A study presented at the annual Pediatric Academic Societies Meeting reveals the early results of the clinical usefulness of rapid whole-genome sequencing in neonatal and pediatric intensive care units (NICUs and PICUs). Children's Mercy Kansas City's STAT-Seq test helped diagnose a genetic disease in more than one half of 35 critically ill infants tested, compared to just nine percent with standard genetic tests. As a result of receiving a specific disease diagnosis, clinical care was refined in 62 percent of infants, including 19 percent who had a markedly favorable change in treatment, and palliative care was initiated in 33 percent. Lead authors of the study were Laurel Willig, MD, Josh Petrikin, MD, and Stephen Kingsmore, MB, ChB, BAO, DSc, FRCPath, of Children's Mercy Kansas City. Still a research protocol, STAT-Seq is the fastest whole-genome test in the world, taking less than 50 hours from test order to delivery of an initial report. STAT-Seq can identify mutations across the genome associated with approximately 5,300 known genetic diseases, and in some cases even identify previously unknown genetic diseases. In contrast, standard clinical practice calls for an array of genetic tests to be performed (94 standard genetic tests were ordered on patients in this study), which are time-consuming, costly and can only test for a limited set of disorders. The symptoms and signs of genetic diseases in neonates are often overlapping, making identification of a specific diagnosis difficult. Further, infants frequently show only a fraction of the full set of symptoms and signs of genetic diseases, further complicating timely diagnosis and specific treatment. STAT-Seq bypasses these difficulties by casting the widest net in defining the underlying etiology. These retrospective results underscore the importance of a larger, prospective, randomized study now under way: In September 2013, Children's Mercy became one of four pilot projects to explore newborn genomics through funding by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Human Genome Research Institute (NHGRI), both parts of the National Institutes of Health. Other projects include teams at Brigham & Women's Hospital at Boston Children's Hospital; University of California San Francisco and University of North Carolina Chapel Hill. Comprised of these four programs, the Newborn Sequencing In Genomic medicine and public HealTh (NSIGHT) program aims to explore, in a limited but deliberate manner, the implications, challenges and opportunities associated with the possible use of genomic sequence information in the newborn period.

Agreement Reached on Audiometric Hearing Test Devices

MAICO Diagnostics and Interacoustics have announced that an agreement has been recognized to offer a full line of hearing testing medical devices to the affiliate hospitals in the buying group. MAICO Diagnostics has been serving hearing healthcare professionals with screening devices since 1937. The agreement includes several of the company's screening and impedance products. Noteworthy is the MB 11, ABR newborn hearing screening device. The device uses patented CE-Chirp stimulus, which significantly reduces test times. Re-usable electrodes and an integrated earphone, means there are virtually no disposables. This significantly reduces medical waste and saves thousands in costly disposables. Interacoustics is the worldwide leader in diagnostic testing equipment. The Titan, otoacoustic emissions, impedance, and ABR device, offers a space saving hand held design that can be customized to meet hospital needs. The members served by Novation (including members of VHA Inc., UHC, Children's Hospital Association and Provista) will be able to purchase a wide variety of audiometric medical devices from MAICO and Interacoustics effective immediately.

Intelligent Ventilation During MRI Procedures

Hamilton Medical has unveiled its HAMILTON‐MR1 ventilator, which allows medical professionals to take patients from the ICU to the MRI suite and back without having to change anything about the ventilation, even when they are on an advanced mode. This diminishes the risks for lung de-recruitment and a patient setback, which would keep patients in the hospital longer and make their stay more uncomfortable. The new Neonatal option now also optimizes the HAMILTON‐MR1 for MR‐compatible neonatal ventilation. With tidal volumes as low as 2 ml, safe, and lung‐protective ventilation of even the most fragile patients is guaranteed. The intelligent leak compensation function IntelliTrig automatically adjusts the inspiratory and expiratory trigger sensitivity to potential leaks. This enables optimal synchronization with the neonate's breathing pattern. The small and rugged housing, an integrated high‐performance turbine, and powerful internal batteries make the HAMILTON‐MR1 ideal for patient transport and easy to handle for the caregiver. The wide range of modern and classic ventilation modes guarantees that before, during, and after the MRI procedure, all of your patients from neonates to adults receive the same high level of ventilation care as at the bedside. The HAMILTON‐MR1 is the first ventilator able to be used at a magnetic field strength of 50 mT, equivalent to 1 m distance for a 3T static magnetic field scanner, without creating any MR image artifacts. Positioning a medical device too close to the MRI scanner can have fatal consequences. For maximum safety, the HAMILTON‐MR1 continuously monitors the magnetic field with TeslaSpy, an integrated gaussmeter, and gives you an audible and visual signal if you are getting too close.

B&B Adds to Team

B&B Medical Technologies announced that respiratory sales and marketing management veteran Stu Novitz has joined its team as the company expands its growing international presence and strengthens its distributor network. Novitz brings with him a wealth of experience working with distributors within the hospital homecare and long-term care market, having recently spent the last four years at Clement Clarke spearheading the company's efforts to extend its reach into the North American medical markets. Joining in advance of B&B Medical's new product rollout, Novitz will make an immediate contribution to the company's continuing success. Novitz joins B&B Medical Technologies as Vice President of Sales and Marketing to advance B&B's reputation for providing specialty airway solutions to clinicians worldwide. "I look forward to working with the management team to further define our action plans that will ensure B&B's long-term growth strategy. I am fortunate to be joining such a respected company with enthusiastic goals for developing innovative, new products," said Novitz. B&B's newest product on the horizon is a solution for the Neonatal Critical Care market and that is only the beginning — the company's development plan is to launch new products each year.

Dispensers Aim to Prevent Mix-ups

NeoMed, a developer and manufacturer of neonatal enteral systems and oral dispensers, has launched its ISMP-compliant Oral Dispensers. The Institute for Safe Medication Practice (ISMP) published their 2014-15 Targeted Medication Safety Best Practices for Hospitals in January 2014. The ISMP recommends in Best Practice #5 to "use liquid medication dosing devices (oral syringes/cups/droppers) that only display volume using the metric scale (mL)". The ISMP hopes to reduce the risk of medication measurement mix-ups by standardizing the method for liquid measurement. In response to this best practice recommendation, NeoMed has removed all teaspoon gradient markings from their Pharmacy Oral Dispenser line. NeoMed offers a full line of amber and clear oral dispensers from sizes 0.5 mL through 60 mL that comply with the ISMP recommendations. NeoMed's oral dispensers feature an O-ring plunger design for smooth and accurate delivery, which aligns with distinct gradient markings for precise measurements. The plugged, hands-free, self-righting tip caps create an airtight and watertight seal to secure the dispenser's contents.

New Name Turns a Corner for Chiesi

Cornerstone Therapeutics Inc., a specialty pharmaceutical company focused on commercializing products for the U.S. hospital and adjacent specialty markets, today announced an official name change to Chiesi USA Inc. following the completion of its acquisition by Chiesi Farmaceutici S.p.A. The acquisition, making Cornerstone a wholly-owned subsidiary of Chiesi, and this name change are the last steps in a process that began when Chiesi became Cornerstone's majority shareholder in 2009. "As Chiesi USA, we look forward to offering our patients and providers more benefits than ever before," said Ken McBean, President of Chiesi USA. "The additional resources made available by this merger will allow Chiesi USA to provide greater support for research and development initiatives while maintaining our commitment to the key therapeutic areas we serve. Being part of a global company also offers our employees additional opportunities for growth and additional support needed to build upon our success." Chiesi USA will continue to market its existing portfolio of products to the hospital and adjacent specialty markets and will actively pursue licensing and acquisition activities in these areas. Chiesi USA's headquarters will remain in Cary, N.C.