Category: CERTIFICATIONS

YorLabs Announces FDA 510(k) Clearance of its Zero-CapEx Intracardiac Imaging System

October 24, 2025

BEAVERTON, Ore., Oct. 24, 2025 /PRNewswire/ — YorLabs, Inc., a medical technology company pioneering next-generation intracardiac imaging solutions for electrophysiology (EP) and interventional cardiology (IC) procedures, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s YorLabs Intracardiac Imaging System – a first-of-its-kind, zero-capex ultrasound platform designed to simplify workflow, reduce cost, and enhance procedural efficiency inside the cath lab.

FDA clears NeurAxis’ neurostimulator for abdominal pain

October 24, 2025

The expanded FDA clearance makes NeurAxis’ IB-Stim the first FDA approval for a treatment that specifically addresses functional dyspepsia.

Edge Medical wins CE mark for surgical robot platform

October 23, 2025

Edge Medical announced on LinkedIn today that it received CE mark for MSP2000, its robotic-assisted “super system.”

Ampa Launches Nationwide Rollout of Portable FDA-Cleared Brain Stimulation System Following $8.5M Oversubscribed Funding Round

October 22, 2025

PALO ALTO, Calif., Oct. 22, 2025 /PRNewswire/ — Four months after emerging from stealth with FDA clearance of the Ampa One system and an oversubscribed $8.5 million round led by Nexus NeuroTech Ventures, Ampa today announced its nationwide rollout. This milestone marks a major step in bringing advanced, non-invasive brain stimulation to patients across the country and brings Ampa’s total funding to $18 million.

Mesh Suture, Inc. Secures Key Regulatory Approvals, Accelerating Global Access to DURAMESH™ for Surgeons Worldwide

October 21, 2025

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.

Onkos Surgical® Receives FDA 510(k) Clearance for ELEOS™ Proximal Tibia with NanoCept® Antibacterial Technology

October 21, 2025

PARSIPPANY, N.J., Oct. 21, 2025 /PRNewswire/ — Onkos Surgical, a leading provider of innovative solutions for complex orthopaedic procedures, announced that it has recently received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ELEOS Proximal Tibia with NanoCept Antibacterial Technology. This marks the first 510(k) clearance for the NanoCept Antibacterial Technology since the original De Novo authorization was granted in April of 2024.

ManaMed® Secures FDA 510(k) Clearance for PlasmaFlow® X — a Breakthrough, Compact Sequential Compression System with All-Day Battery

October 20, 2025

DENTON, Texas, Oct. 20, 2025 /PRNewswire/ — ManaMed today announced FDA 510(k) clearance for PlasmaFlow® X, the next-generation, tubeless sequential compression system that’s redefining recovery. Cleared as a Class II device, PlasmaFlow X is more compact, smarter, and longer-lasting—delivering powerful therapy in a sleek, portable package.

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