Phoenix Children’s Hospital will be the first health system in the U.S. to deploy the newly FDA-cleared Medtronic Stealth Autoguide platform to perform robotic neurosurgery on pediatric patients. The Barrow Neurological Institute (BNI) at Phoenix Children’s will use Stealth Autoguide with Medtronic’s StealthStation system. The hospital expects procedures to start later this month, according to […]
OrthoPediatrics sells off Vilex assets related to adults
OrthoPediatrics (NSDQ:KIDS) announced today that it completed the sale of substantially all of the assets related to the adult product offering of Vilex in Tennessee to Squadron Capital affiliate Vilex. The divestiture was completed on Dec. 31, 2019, after OrthoPediatrics reported its plan to divest the Vilex adult business when it acquired Vilex in Tennessee in […]
PhotoniCare wins FDA nod for imaging tech to spot ear infections
PhotoniCare announced today that it won FDA 510(k) clearance for its TOMi Scope for non-invasive imaging of the middle ear to spot ear infections and more. The TOMi Scope is designed to determine the presence or absence of fluid in the middle ear, as well as to characterize the fluid type, by using optical coherence […]
Masimo’s improved pulse oximetry tech now available to all U.S. newborns
Masimo (NSDQ:MASI) has won FDA clearance for pulse oximetry sensors with improved oxygen saturation accuracy specifications for newborns over 3 kg in weight. Masimo touted significantly improved performance specifications for the RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry. The improved specs were already available for babies under 3 kg, so […]
FDA clears Cochlear piezoelectric hearing implant
The FDA has cleared a second-generation pioezoelectric bone-conduction hearing implant from Cochlear (ASX:COH), the company announced today. The Osia 2 system is an active osseointegrated, steady-state implant (OSI) that uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear. It is designed to […]
Tusker Medical’s pediatric ear tubes land breakthrough device designation
The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of the […]
FDA approves CooperVision’s contact lens to slow nearsightedness in kids
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 […]
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