MedTech News
FDA clears Clario’s SpiroSphere® with wireless ECG, streamlining data collection in clinical trials
With the FDA 510(k) clearance of the COR-12 wireless ECG device now integrated with the SpiroSphere®, sponsors can conduct comprehensive respiratory trials with cardiac safety ECG collection on one device.
New FDA Cleared Balloon Catheter Used for Vessel Occlusion During Patient Resuscitation
Temporary vessel occlusion a growing practice for trauma patients.
Philips launches Duo venous stent system with FDA approval
Philips (NYSE: PHG) today announced the first implant of its Duo venous stent system following FDA premarket approval.
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.