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 […]
De Novo 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 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 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 […]
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.