The FDA granted pre-market approval for the Amplatzer Piccolo occluder made by Abbott (NYSE:ABT) to treat a congenital heart defect in neonatal infants as small as two pounds, the company said today. The Chicago-area healthcare giant said Amplatzer Piccolo is a transcatheter, self-expanding, wire mesh device that’s inserted via the aortic or pulmonary artery to close a […]
Empatica’s pediatric seizure-predicting smartband wins FDA nod
Empatica said that its Embrace epilepsy smartband has received 510(k) clearance from FDA for use in children, a year after winning clearance for adults with epilepsy. Embrace was designed to detect motion patterns and physiological signals that may be associated with generalized tonic-clonic (“grand mal”) seizures and immediately alert caregivers. It is the first non-EEG based, […]
FDA green-lights pediatric indication for Paragonix’s SherpaPak heart transport device
Paragonix Technologies said today that the FDA granted 510(k) clearance for a design change to its SherpaPak heart transport device so that it can be used with small and pediatric hearts. Braintree, Mass.-based Paragonix said it will begin shipping heart connectors covering most aortic diameters during the first quarter of 2019. “This FDA clearance is an […]
OrthoPediatrics announces pricing of common stock offering
OrthoPediatrics (NSDQ:KIDS) said today it will price an underwritten follow-on public offering of 1.5 million shares of its common stock at $27 per share. The company said it plans to use the proceeds of offering to invest in implant and instrument sets for consignment to its customers, fund research and development activities, expand its sales and […]
Vapotherm touts automated oxygen controller in preemie study
A recent clinical trial showed that Vapotherm’s (NYSE: VAPO) new IntellO2 module for its Precision Flow system greatly improved the chances of keeping premature babies in the target oxygenation range. The prospective, multi-center, controlled, order-randomized crossover trial demonstrated that using the IntellO2 module helped clinicians maintain newborns in the physician-prescribed oxygen saturation range 80% of the time, compared with 49 % […]
Wishbone Medical picks up pediatric device maker Response Ortho
WishBone Medical said this week that it acquired Turkish pediatric fixation device maker Response Ortho for an undisclosed amount. Istanbul-based Response’s portfolio includes 30 pediatric orthopedic systems; WishBone had eight before the acquisition, the Warsaw, Ind.-based company said. Eighteen of the Response Ortho products are cleared or approved for the U.S. market. Wishbone said it’s opursuing […]
Natus takes a hit on Q3 misses
Investors pushed share prices down today for Natus Medical (NSDQ:BABY) after the neonatal care company missed expectations with its third-quarter results. Pleasanton, Calif.-based Natus pared its losses by -34.5% to -$5.6 million, or -17¢ per share, on sales growth of 6.5% to $130.6 million for the three months ended Sept. 30, compared with Q3 2017. […]
11 pediatric cardiovascular devices you need to know about
A bandage-sized heart monitor, an extracorporeal blood pump that mimics the human heart, and a heart valve that can grow with a child were among the six winners of a contest in Philadelphia for innovative pediatric cardiovascular devices. The Pediatric Device Innovation Symposium organized by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National […]
FDA puts $7m into L.A. pediatric devices consortium
The FDA awarded a $6.6 million, five-year grant to the West Coast Consortium for Technology and Innovation in Pediatrics to help support the continued development of advanced pediatric medical products, according to a press release from the group. The consortium, based out of the Children’s Hospital Los Angeles and the University of Southern California, touted […]
Study: Home baby pulse oximetry monitors may be inaccurate, unnecessary
Baby monitors designed to track physiological conditions may be inaccurate and cause parents more stress than necessary, according to a new report published in the Journal of the American Medical Association. Researchers at the Children’s Hospital of Philadelphia studied two such monitors, the Owlet Smart Sock2 and the Baby Vida, both of which are not […]
Report: FDA’s Gottlieb says pediatric device approvals are lagging
FDA head Scott Gottlieb said that over the past 10 years there have been “far too few” devices hitting the US market designed specifically for a pediatric population, according to a recently posted Regulatory Affairs Professionals report. The statement came at a two-day FDA workshop this week, according to the report. Barriers including sample size […]
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