Medical imaging AI company receives approval for algorithm enabling opportunistic detection and triage of vertebral compression fractures.
Challenge Works today announces that Sysmex Astrego’s PA-100 AST System has won the $10m (£8m) Longitude Prize on AMR.
Abbott (NYSE: ABT)+ today announced FDA clearance for two over-the-counter continuous glucose monitor (CGM) systems, Lingo and Libre Rio.
DeepQure announced today that it received FDA investigational device exemption (IDE) approval for a study of its HyperQure system.
CroíValve today announced favorable patient outcomes in a first-in-human clinical trial of its Duo tricuspid coaptation valve system.
Johnson & Johnson MedTech‘s DePuy Synthes announced today that it received a new FDA 510(k) clearance for its Velys surgical robot platform.
Mequ announced today that the FDA granted 510(k) clearance to its M Warmer system, a portable blood and IV fluid warmer platform.
Amplitude Vascular Systems announced today that it received FDA investigational device exemption (IDE) for its pulsatile intravascular lithotripsy (PIVL) therapy.
Abbott (NYSE: ABT)+ announced today that it received CE mark approval for its Aveir dual-chamber (DR) leadless pacemaker system.
Enspectra Health, a health tech company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its next generation AI-powered VIO™ Skin Platform (VIO)