Tag: Medical Devices
Radiology AI that clears Europe first faces a 17.5-month FDA wait
CE-first radiology AI waits a median 17.5 months for FDA clearance, an npj analysis finds.
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 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.
Ceribell’s AI EEG readers clear FDA review
The FDA cleared two Ceribell AI algorithms that detect epileptiform patterns and clean up EEG recordings on its Neurology Portal.
GE HealthCare rolls out AI breast ultrasound pair for dense tissue screening
GE HealthCare launches an AI-powered automated breast ultrasound system and a browser-based remote viewer for dense breast screening.
EU AI Act high-risk rules now bind health AI developers
The EU AI Act's high-risk obligations took effect August 2, with AI medical software bound now and CE-marked devices getting…