FDA

FDA grants digital therapeutic for Alzheimer's symptoms Breakthrough Device designation
By Dave Muoio | 04:29 pm | August 23, 2018
As laid out in the 21st Century Cures Act, the Breakthrough Devices Program looks to streamline new medical technologies that offer improved treatment for serious diseases.
Healthy.io gets FDA nod for smartphone camera-based home urine test
By Jonah Comstock | 10:43 am | July 25, 2018
Senseonics gets FDA clearance for Eversense, will sell implantable glucose monitor directly in US
By Jonah Comstock | 12:58 pm | June 22, 2018
FDA's second draft shows Pre-Cert is coming along, still has a ways to go
By Jonah Comstock | 05:45 pm | June 20, 2018
FDA clears MindMaze's gamified home-neurorehabilitation platform
By Dave Muoio | 03:26 pm | June 12, 2018
FDA makes premarket exemption official for genetic risk assessments
By Jonah Comstock | 02:20 pm | June 04, 2018
FDA launches innovation challenge to help stem opioid crisis
By Bernie Monegain | 05:17 pm | May 30, 2018
MC10 gets its first FDA clearance for BioStamp nPoint, a sensor platform for clinical trials
By Jonah Comstock | 05:30 pm | May 16, 2018
FDA chief sees big things for AI in healthcare
By Mike Miliard | 10:13 am | April 30, 2018
As FDA's Pre-Cert plan takes shape, worries emerge about overreach
By Jonah Comstock | 05:43 pm | April 26, 2018