December FDA Panel Meeting Set For Stroke Patient Implant
Executive Summary
Brainsgate’s ISS500 can reportedly lessen stroke symptoms if put into use within 24 hours of the onset of symptoms.
You may also be interested in...
US FDA Panel Says No To BrainsGate Stroke Device That Missed Efficacy Endpoints
While a panel of agency experts agreed the stroke recovery device was safe, most agreed it had not proven it was effective enough to be allowed on the market yet.
Report Finds Digital Diabetes Tools Deliver No ‘Meaningful Clinical Benefits'
A new report from health economics group the Peterson Health Technology Institute found that apps to help patients manage their blood sugar levels delivered few of the promised benefits. However, a digital therapeutics industry association says PHTI’s research cast too narrow a net.
FDA Leader Looks To International Effort On Pediatric Device Development
Collaboration with Japan and Europe could help ease the development path for pediatric devices, cardiovascular device office director Bram Zuckerman said at a recent conference. Zuckerman also spoke on other cardiac device priorities at the FDA.