The MAGiC catheter is designed to perform minimally invasive cardiac ablation procedures that treat various forms of ...

Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...

Abbott’s Volt pulsed field ablation system — for the treatment of atrial fibrillation. The Volt system delivers high-energy electrical pulses to targeted areas of the heart to disrupt abnormal rhythms ...

The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.

Edwards Lifesciences has claimed an FDA approval for its Sapien M3 transcatheter mitral valve replacement system—marking the agency’s first in this type of implant that takes a potentiall | The ...

Yale surgeons have completed Connecticut’s first FDA-approved TAMBE procedure, marking a shift in the treatment of complex aortic aneurysms. On Aug. 7, vascular surgeons at Yale New Haven Hospital ...

Johnson & Johnson MedTech announced today that it submitted its Ottava surgical robotic system to the FDA for de novo ...

FDA approvals in 2025 introduced novel therapies and devices across ophthalmic subspecialties, emphasizing sustained efficacy ...

ST. LOUIS — A newly FDA-approved procedure allows patients to regrow their own knee cartilage using autologous cell implantation. The treatment, known as MACI (Matrix Autologous Chondrocyte ...

Elon Musk’s Neuralink will begin mass production of brain implants by 2026, following FDA approval and $650M funding. The ...

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA nod ...