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.
The expanded FDA clearance makes NeurAxis’ IB-Stim the first FDA approval for a treatment that specifically addresses functional dyspepsia.
Edge Medical announced on LinkedIn today that it received CE mark for MSP2000, its robotic-assisted “super system.”
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.
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.
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.
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.
Glaukos (NYSE:GKOS) announced today that the FDA approved its Epoxia incision-free alternative to traditional corneal cross-linking procedures.
Rhythio Medical announced today that it received FDA breakthrough device designation for its Injectable Electrode System.
The clearance led to the deployment of the instrument across various medical facilities in the UK and Europe.
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.