MedTech News
FDA clears new cervical cytology AI tech from Hologic
Hologic (Nasdaq: HOLX)+
announced that the FDA granted clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm.
Edwards receives FDA approval for first transcatheter tricuspid valve replacement treatment
The Evoque valve will serve patients with few treatment options, wrote RBC analyst Shagun Singh.
Fractyl Health goes the IPO route
Fractyl Health — developer of medtech and gene therapies to reverse diabetes and obesity — began trading on the Nasdaq today under the symbol GUTS.
SeaStar Medical Granted Canadian Patent with Broad Claims Covering the Selective Cytopheretic Device Technology
SeaStar Medical Holding Corporation (Nasdaq: ICU) announces the issuance by the Canadian Intellectual Property Office of Canadian Patent No. 2814586
FDA clears latest Philips TEE transducer for cardiac care
Philips (NYSE: PHG)+
announced today that the FDA granted 510(k) clearance to its latest TEE transducer technology.
InspireMD wins CE mark for carotid stent system
InspireMD (Nasdaq:NSPR) announced today that it received CE mark approval for its CGuard embolic prevention carotid stent system (EPS).
Boston Scientific Receives FDA Approval for FARAPULSE™ Pulsed Field Ablation System
Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique new alternative to standard-of-care thermal ablation treatment.
W. L. Gore & Associates, Inc. Receives U.S. Food & Drug Administration (FDA) Approval for Lower Profile Gore® Viabahn® VBX Balloon Expandable Endoprosthesis, Now 6 FR Sheath Compatible
With improvements to the stent graft delivery system enabling a 1 Fr profile reduction on the majority of sizes, the device now offers the most 6 Fr compatible configurations among balloon expandable stent grafts.