
Intuitive gets expanded FDA nod for AI, imaging integration for Ion
ntuitive Surgical (Nasdaq: ISRG)+
announced today that it received FDA clearance for new software advancements for its Ion endoluminal robot.

ntuitive Surgical (Nasdaq: ISRG)+
announced today that it received FDA clearance for new software advancements for its Ion endoluminal robot.

SALT LAKE CITY, Oct. 7, 2025 /PRNewswire/ — Xenocor, Inc., a leader in single-use surgical visualization, proudly announces the issuance of U.S. Patent No. 12,429,685 B2 for its innovative medical borescope and tip assembly technology. This milestone reinforces Xenocor’s commitment to advancing safe, efficient, and accessible minimally invasive procedures through disposable and digitally optimized laparoscopic tools.

Vektor Medical today announced it received CE mark approval for its vMap artificial intelligence-powered arrhythmia mapping system.

GROVE CITY, Ohio, Oct. 6, 2025 /PRNewswire/ — Tosoh Bioscience, Inc., a market leader in clinical diagnostics is proud to announce that it has received US FDA 510(k) clearance for its next-generation system for HbA1c testing – the Tosoh Automated Glycohemoglobin Analyzer HLC®723-GR01 (hereafter “GR01”). The GR01 is intended for monitoring the long-term blood glucose control of individuals with diabetes, as an aid in the diagnosis of diabetes and to help identify those who may be at risk of developing the disease.

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.