FDA

Deloitte report offers guidance for FDA's upcoming software regulation pathway
By Dave Muoio | 04:40 pm | March 13, 2018
FDA clears Medtronic's smartphone-connected CGM for MDI users
By Jonah Comstock | 06:36 pm | March 12, 2018
FDA recognizes Cognoa's child development app as autism diagnostic
By Dave Muoio | 10:58 am | February 21, 2018
Roche’s Accu-Chek diabetes management app receives its fifth FDA recall
By Dave Muoio | 04:55 pm | February 20, 2018
FDA budget requests include clinical software, natural language processing, real-time device data
05:20 pm | February 15, 2018
Viz.ai’s stroke-detecting CDS app receives FDA nod
By Dave Muoio | 05:07 pm | February 14, 2018
Clinical Decision Support Coalition letter criticizes FDA's stance on CDS
By Laura Lovett | 02:41 pm | February 06, 2018
Empatica's consumer-facing epileptic seizure-detecting wearable gets FDA clearance
By Jonah Comstock | 01:01 pm | February 05, 2018
FDA's first Pre-Cert workshops give industry and agency a chance to talk
By Laura Lovett | 05:28 pm | February 01, 2018
Heart Study app could be Apple's first FDA-cleared product
By Jonah Comstock | 04:23 pm | February 01, 2018