Tag: FDA
Surgical robots get their own FDA playbook, open for comment
The agency wants comments by Nov. 24 on how robotic surgery makers should test, document and label their systems.
Glytec aims its insulin algorithm at newborns in the NICU
The designation covers newborns and infants under two, a population with no FDA-cleared insulin dosing software.
FDA backs LLM juries to grade AI-written radiology reports
A $1.29M FDA contract will test whether several language models, supervised by radiologists, can evaluate AI-generated reports across roughly a…
ARPA-H bets $62.7M on AI agents for heart failure care
The health research agency has named the teams that will build an autonomous clinical AI agent for patients living with…
FDA pilot lets generative AI health apps launch without premarket review
Cadence and Limbic are among four products accepted into the FDA's TEMPO pilot for release before authorization.
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.