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.

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