The FDA has approved the first contact lens indicated to slow the progression of nearsightedness in children between the ages of 8 and 12 years old. The MiSight contact by CooperCompanies’ (NYSE:COO) CooperVision lens is a single-use, disposable, soft contact lens that is discarded at the end of each day and is not intended to be worn […]
Teleflex says infant breathing device it distributes is recalled
Teleflex (NYSE:TFX) today announced a recall of a device used to help newborns with infant respiratory distress syndrome to breathe. Teleflex is one of the U.S. distributors of the device, the Babi.Plus 12.5 cm H2O pressure relief manifold, manufactured by GaleMed. The FDA has designated the recall as Class I. The recall began June 14 […]
Abbott wins CE Mark for pediatric heart devices
Abbott (NYSE:ABT) said today that it won CE Mark approval for its Masters HP mechanical heart valve and Amplatzer Piccolo occluder. The Masters HP is the world’s smallest mechanical heart valve (15mm) and is designed for implantation in the mitral or aortic position to mimic a healthy heart valve by opening and closing to facilitate blood […]
WishBone Medical to launch growth control plating system for kids
WishBone Medical today said it will launch its growth control plating system for kids at the end of September this year. The growth control plating system is a single-use procedure kit in sterile packaging that is designed to treat angular limb deformities in children. Physicians can use the growth control plates to redirect the growth […]
How to produce more medical devices for kids
FDA recently reported a startling fact: Most of the pediatric medical devices approved in fiscal 2017 were originally intended for adults. Health providers, especially in NICUs, are continually altering devices in order to do all they can to save infants and children, but the situation is not ideal, Michael Drues, a regulatory consultant based in […]
Teva launches generic EpiPen Jr.
Teva (NYSE:TEVA) today announced that its FDA-approved generic EpiPen Jr. auto-injector is available in the U.S. The device wholesales to most retail pharmacies in packs of two for $300, or $150 per pen. Teva’s product is less than half the cost of Mylan’s non-generic EpiPen Jr., which lists at $643.89 per two-pack at Drugs.com. Get the full story at […]
Masimo lands CE Mark for infant hemoglobin monitor
Masimo (NSDQ:MASI) said it has won the CE Mark for a noninvasive and continuous hemoglobin monitor for newborn and infant patients weighing less than 3 kg (6.61 lbs.). SpHb uses the company’s Rainbow sensors, which allow clinicians to simultaneously measure multiple additional noninvasive parameters alongside SpHb, including oxygen saturation (SpO2) and methemoglobin (SpMet). Current […]
Teleflex recalls neonatal breathing devices
Teleflex (NYSE:TFX) is recalling its Neonatal ConchaSmart breathing circuit with dual heated limb and ConchaSmart Column due to complaints of cracks being observed, prior to use, on the device’s swivel wye adaptors. Cracks in the adaptor may cause breathing distress from insufficient oxygenation because the gas may leak and not reach the patient. The FDA has […]
FDA warns of magnetic interference involving hearing devices
The magnets in some hearing implants may interfere with the operation of programmable cerebrospinal fluid (CSF) shunt systems used to treat hydrocephalus, causing over- or under-drainage, the FDA warned yesterday. Magnetic interactions between cochlear implants, bone-conduction hearing devices or middle-ear hearing devices implanted too closely to shunt systems may “ lead to unintended changes to […]
FDA: Most new pediatric devices designed for adults
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 […]
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