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 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 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 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.