Tag: Medical Devices
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…