The FDA approved, cleared or authorized a record high of 132 novel medical devices in 2020, with pandemic-related emergency use authorizations (EUAs) adding significantly to the total. That compares with 29 novel devices the agency authorized in 2010, according to a new article by officials from the agency’s Center for Devices and Radiological Health (CDRH). […]
De Novo Clearance
Baxter’s dialysis filter wins De Novo nod
Baxter (NYSE:BAX) announced today that it received FDA De Novo classification for its Theranova novel dialysis membrane. Theranova is designed to deliver expanded hemodialysis (HDx) therapy, filtering a wider range of molecules from the blood than traditional hemodialysis (HD) filters, targeting certain molecules associated with inflammation and cardiovascular disease in patients with kidney failure, according to […]
Medtronic wins pediatric blood-filtering device clearance
The FDA yesterday granted de novo clearance to a Medtronic (NYSE:MDT) device designed to provide continuous dialysis in critically ill young children. The Carpediem extracorporeal blood-filtration system was designed to provide continuous renal replacement therapy (CRRT) to critically ill patients weighing 5.5 to 22 lb. These patients must have a sudden or temporary loss of kidney […]
BrainsWay wins ‘historic milestone’ clearance to treat OCD
BrainsWay said it has won de novo clearance from the FDA for its deep transcranial magnetic stimulation (Deep TMS) system for treatment of obsessive-compulsive disorder (OCD) in adults. The clearance marks the second indication granted for BrainsWay Deep TMS, and the first noninvasive medical device clearance for the treatment of OCD. The FDA cleared the device […]
Claret Medical wins de novo FDA nod for Sentinel TAVR filter
Claret Medical said today that the FDA granted de novo clearance for its Sentinel device, which is designed to trap blood clots before they reach the brain during heart valve replacement procedures. The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic […]
Augmenix wins FDA nod for SpaceOar prostate treatment
FDA clearance in hand, Augmenix is formulating U.S. commercial sales and insurance reimbursement plans for a medical gel designed to help protect the rectum during prostate cancer radiotherapy, CEP John Pedersen told MassDevice.com today.
Edap bails on Ablatherm PMA, to seek de novo clearance from FDA
FDA approves Pelvalon’s fecal incontinence device
Diabetes: FDA clears DexCom’s mobile apps
Dexcom Inc. (NSDQ:DXCM) won de novo approval from the FDA for the 1st U.S. app to wirelessly connect a patient’s blood glucose monitor with up to 5 mobile devices.