Tag: Medical Devices
Maverix secures 510(k) for its console-free Narwhal Pro lung cryoprobe
A 510(k) clearance has been won by Maverix Medical for the Narwhal Pro Cryo System, the second of two flexible…
Samsung spinoff wins FDA clearance for AI ECG analysis software
Wellysis pairs its cleared S-Patch hardware with CardioAI, moving the company from collecting heart data to interpreting it.
FDA clears software that builds 3D bone from a routine spine MRI
NextMR renders a patient's lumbar spine and sacrum in 3D from a routine MRI in under 60 seconds, aiming to…
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.