Most of the 66 medical devices that the FDA approved for pediatric patients in the 2017 fiscal year were initially intended and approved for adults, the agency said in a new annual report to Congress. Of the total, 16 were premarket approvals (PMAs) and two were humanitarian device exemptions (HDEs) specifically designed for children. The […]
BD recalls SmartSite syringe administration set
Becton Dickinson (NYSE:BDX) recalled nearly 3,000 leaky SmartSite syringe administration sets used in the neonatal intensive care unit in what the FDA deemed a Class I action. Franklin Lakes, N.J.-based BD issued an urgent medical device recall in February involving 2,900 of its SmartSite syringe administration sets, which are used with infusion pumps to deliver medication, blood and […]
How a video game could treat ADHD
Attention-deficit hyperactivity disorder makes it harder for people to pay attention and control impulsive behavior. It is one of the most common neurobehavioral disorders in children, according to the CDC. The treatment options for ADHD include behavioral therapy and medication intervention, but what if kids could use video games to treat the disorder? Akili Interactive, […]
Natus Medical shares slide on earnings restatement
Shares in Natus Medical (NSDQ:BABY) took a hit today after the medical device maker restated its first-quarter earnings after discovering an accounting error. Last month the Pleasanton, Calif.-based company posted losses of approximately -$24.8 million, or -74¢ per share, on sales of approximately $114.8 million for the three months ended March 31, seeing losses grow 687% while […]
5 pediatric orthopedic devices you need to know
The National Capital Consortium for Pediatric Device Innovation recently recognized five pediatric orthopedic devices that could improve scoliosis treatment, clubfoot assessment and surgical imaging. The five winners of the NCC-PDI’s “Make Your Medical Device Pitch for Kids!” competition — announced May 1 — will each receive $50,000 in grant funding and access to the consortium’s […]
EO plant shutdown leads to pediatric breathing tube shortage
The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA. The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to […]
Wireless preemie monitoring system allows more parental contact
A new, less invasive system for monitoring preterm and critically ill newborns’ vital signs would allow parents skin-to-skin contact with their babies when they otherwise couldn’t have it. The system, designed by researchers at Northwestern University in Chicago, uses ultrathin, skin-like electronic sensing technology to overcome the limitations of traditional systems that require a large […]
Abbott wins FDA approval for Amplatzer Piccolo occluder for neonates
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 […]
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