Accelus today announced it received FDA 510(k) clearance for its FlareHawk Interbody Fusion System to be safely scanned under certain MRI conditions
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.
IceCure has 20+ patents in the U.S. and the Company anticipates further market traction upon FDA’s marketing authorization decision in early-stage breast cancer
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.
Regulatory Milestone Validates JBA AI’s Clinical-Grade Software for Advanced Diagnostic Support
BiVacor announced today that it received FDA breakthrough device designation for its Total Artificial Heart (TAH) system.
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.