GlucoSet wins FDA breakthrough nod for glucose biosensor tech
October 3, 2025
GlucoSet announced today on social media that it received FDA breakthrough device designation for its glucose monitoring technology.
GlucoSet announced today on social media that it received FDA breakthrough device designation for its glucose monitoring technology.
IceCure Medical (Nasdaq:ICCM) announced today that the FDA granted marketing authorization for its ProSense cryoablation system for breast cancer.
Hologic’s FDA clearance for its Panther Fusion GI Bacterial and Expanded Bacterial Assays represents the company’s entry into the gastroenteritis test market.
Distalmotion announced today that it received FDA 510(k) clearance for the use of its Dexter robotic surgery system in hysterectomy.
Medtronic (NYSE: MDT)+
announced today that it received CE mark approval for its Penditure LAA exclusion system.
NEW YORK, Sept. 30, 2025 /PRNewswire/ — Aidoc, the global leader in clinical AI, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s novel multi-triage solution that flags a wide array of life-threatening, time-sensitive medical conditions, all within a single workflow. Built on CARE™, the first clinical-grade foundation model in healthcare with FDA cleared solutions, and deployed through Aidoc’s aiOS™ platform, the solution is designed to help care teams attend to high–risk cases faster and more consistently across the health system.
SAN FRANCISCO, Sept. 30, 2025 /PRNewswire/ — Avive Solutions, Inc. is proud to announce a significant advancement in public safety and emergency preparedness: the smallest, lightest AED on the market, the Avive Connect AED®, is safe and effective for use on aircrafts. Following rigorous testing and evaluation, this clearance confirms that the device is safe and effective for use on aircraft, enabling a new standard of emergency response at 30,000 feet.
Zenflow announced today that it received FDA 510(k) clearance for its Spring scope and camera control unit (CCU).
Outlook Surgical this week announced it received FDA 510(k) clearance for its Inova 1 Towerless Endoscope System.
Zoll announced today that it received FDA premarket approval (PMA) for its Zenix professional monitor/defibrillator.