Tag: FDA clearance
SimBioSys wins FDA clearance for an MRI-based breast cancer risk score
SimBioSys has secured 510(k) clearance from the FDA for TumorSight Risk, a prognostic tool that estimates breast cancer recurrence risk…
E2 picks up two FDA clearances for its clot-removal platform
Two FDA 510(k) clearances have been granted to Endovascular Engineering, the company known as E2, covering its Helo thrombectomy system…
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…
OptraSCAN wins FDA clearance for a high-throughput slide scanner
The digital pathology vendor is taking its cleared OS-Ultra system to Pathology Visions 2026 with a push toward higher-volume labs.
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…
Tempus adds a leaky heart valve to what an ECG can flag
Tempus won clearance for software that reads a routine heart tracing for signs of undiagnosed mitral regurgitation.
An AI now flags the frames from a swallowed camera
CapsoVision's software won FDA clearance to mark suspicious images in small-bowel capsule studies and cut review time.