CHICAGO, Oct. 21, 2025 /PRNewswire/ — Mesh Suture, Inc. (MSi), a company focused on redefining the standard for surgical closure, today announced it has achieved two major regulatory milestones for DURAMESH™, its flagship product for surgical repairs. Notably, MSi has obtained certifications under both the European Union Medical Device Regulation (EU MDR) and the Medical Device Single Audit Program (MDSAP), reflecting the company’s continued commitment to delivering safe and effective surgical closure solutions globally.

Rhythio Medical announced today that it received FDA breakthrough device designation for its Injectable Electrode System.

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.