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.
Abbott (NYSE: ABT)+
said Health Canada authorized its Esprit BTK Everolimus Eluting Resorbable Scaffold System, a dissolving stent for patients with chronic limb-threatening ischemia (CLTI) below the knee.
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it received approval to deliver Lyumjev ultra-rapid acting insulin with its t:slim X2 pump.