HOUSTON, June 9, 2025 /PRNewswire/ — TYBR Health, a medical device and regenerative medicine company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the B3 GEL™ System. B3 GEL™ is a bioresorbable, flowable gel barrier designed to protect healing tissue planes and preserve mobility following surgeries involving tendons, ligaments, and skeletal muscle.

Non-Invasive Histotripsy Technology Authorized Under Unmet Clinical Needs Pathway for Liver Tumor Treatment

First-of-its-Kind Retrievable Stent Gains Approval for Treating Challenging Below-the-Knee Peripheral Artery Disease

Terumo Interventional Systems has announced the early commercial availability of its FDA-approved Roadsaver Carotid Stent System.

CoreMap announced that it received FDA investigational device exemption (IDE) to extend its electrophysiology (EP) mapping trial to the U.S.

SAN FRANCISCO, May 29, 2025 /PRNewswire/ — Darmiyan, Inc., a leading brain health technology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s post-market surveillance study for BrainSee, its groundbreaking clinical prognostic tool for Alzheimer’s disease. This 7-year study aims to further validate the safety and effectiveness of BrainSee in a socio-demographically diverse patient population across the United States. The insights gained will also support pharmaceutical companies and contract research organizations (CROs) in identifying optimal candidates for next-generation Alzheimer’s clinical trials—advancing both precision and equity in patient selection.