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.

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

The FDA has approved Deseyne contact lenses with extended depth of focus for the correction of presbyopia, according to a ...

After claiming its approval in Europe earlier this year, Abbott has secured the FDA’s go-ahead for its Volt pulsed field ablation system for irregular heart rhythms, a step forward in an | With the U.

Edwards Lifesciences has claimed an FDA approval for its Sapien M3 transcatheter mitral valve replacement system—marking 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 ...

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 ...

Here are 40 spine devices and technologies earning FDA clearances in 2025. Note: This is not an exhaustive list. 1. SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a ...

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 ...