Tag: Medical Devices
GE HealthCare recruits Medtronic’s AI chief to steer its strategy
Rodolphe Katra, who built Medtronic's enterprise AI center of excellence, will run AI strategy across GE HealthCare's devices, software and…
Ackman’s first private check buys into a 1,024-electrode brain implant
The Ackman-backed round funds a surface array that reads brain signals without pushing electrodes into tissue.
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.
An algorithm could triage the FDA’s 510(k) pile and catch recalls
A Management Science study found a human-plus-algorithm review model could cut device review workload and catch more unsafe devices.
Medtronic wins FDA nod to bring LigaSure onto the Hugo robot
The clearance puts Medtronic's vessel-sealing technology, used in 45 million procedures, onto its own robotic surgery platform.
12,000 voices shape UK plan for staged medical AI licenses
A doctor-led commission has handed the MHRA a roadmap that would put new medical AI models on probation before full…
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.
Stryker’s Vision Pro surgery app completes first hip case
SportSuite Vision, the first FDA-authorized app for intraoperative use on Apple's headset, debuts at Duke Health.