First-in-class gene therapy moves toward clinical trials to address a life-threatening genetic heart condition with high unmet need

Medtronic has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Visualase V2 MRI-Guided Laser Ablation System. This milestone brings important capital system enhancements to the Visualase platform, which provides a minimally invasive surgical option for patients with focal epilepsy, brain tumors, and radiation necrosis, which impacts over 1 million people total worldwide.

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.