MedTech News
FDA clears clinical decision software from Getinge
Getinge announced today that it received FDA 510(k) clearance for its Talis +ACG (advanced clinical guidance) support software.
Avicenna.AI secures FDA clearance for AI detection of vertebral compression fractures
Medical imaging AI company receives approval for algorithm enabling opportunistic detection and triage of vertebral compression fractures.
From 3 days to 45 minutes: rapid test for UTI wins $10m Longitude Prize on AMR to transform fight against superbugs
Challenge Works today announces that Sysmex Astrego’s PA-100 AST System has won the $10m (£8m) Longitude Prize on AMR.
Abbott wins FDA clearance for duo of over-the-counter CGMs
Abbott (NYSE: ABT)+ today announced FDA clearance for two over-the-counter continuous glucose monitor (CGM) systems, Lingo and Libre Rio.
DeepQure wins FDA IDE nod for renal denervation study
DeepQure announced today that it received FDA investigational device exemption (IDE) approval for a study of its HyperQure system.
CroíValve reports positive first-in-human valve repair data
CroíValve today announced favorable patient outcomes in a first-in-human clinical trial of its Duo tricuspid coaptation valve system.
J&J’s DePuy Synthes wins new FDA clearance for Velys surgical robot
Johnson & Johnson MedTech‘s DePuy Synthes announced today that it received a new FDA 510(k) clearance for its Velys surgical robot platform.
FDA clears portable blood, IV fluid warmer from Mequ
Mequ announced today that the FDA granted 510(k) clearance to its M Warmer system, a portable blood and IV fluid warmer platform.