SANTA MONICA, Calif. and NETANYA, Israel, Oct. 15, 2025 /PRNewswire/ — CAPS Medical, a clinical-stage MedTech company developing a platform for selective tumor ablation across multiple indications, today announced that its PlasmaSure™ System has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC). The PlasmaSure™ platform delivers non-thermal atmospheric plasma energy through the working channels of standard minimally invasive tools, in the case of NMIBC, through cystoscopes, enabling highly selective, tissue-preserving tumor ablation.

Stereotaxis (NYSE:STXS) announced today that it received CE mark for its Synchrony system while also submitting it to the FDA for 510(k) clearance.

BVI announced today that the FDA approved its FineVision HP trifocal intraocular lens (IOL) for cataract surgery.

Zeta Surgical this week announced it received FDA 510(k) clearance for its Zeta TMS Navigation System

Pleural Dynamics announced today that it received a new CMS code for its ACES (automatic continuous effusion shunt) device.

Medtronic (NYSE: MDT)+
announced today that it received new labeling approval from the FDA for its Endurant stent graft system.