Tag: FDA
Medtech veteran tipped to lead AI oversight at FDA
HHS is standing up two new FDA deputy commissioner posts, with a medtech veteran tipped to oversee AI.
FDA outlines three-stage path for digital measures in trials
FDA centers lay out a three-stage evidence path for wearable and sensor trial endpoints.
Study finds almost no FDA-cleared AI devices tested on outcomes
A PLOS Digital Health study finds only three of 1,357 FDA-cleared AI devices were ever tested on patient outcomes.
FDA gives first US clearance to Vitestro’s vein-finding blood draw robot
The FDA cleared Vitestro's Aletta as the first fully autonomous blood draw system in the US.
FDA roster of cleared AI medical devices passes 1,500
FDA marketing authorizations for AI-powered medical tools have passed 1,500, with oncology among the fastest-growing categories.
FDA maps a doctor-like testing path for generative AI devices
The FDA's new discussion paper proposes doctor-style competency testing for generative AI medical devices before they reach patients.
FDA and CMS court AI health startups in closed-door demo day
FDA and CMS hosted 10 AI health companies at a private demo day as they weigh clinical AI policy.
White House convenes clinical AI experts for standards sprint on evaluation
The White House, FDA, and ONC launch a month-long effort to create consensus principles for clinical AI benchmarking.