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 ...

Stereotaxis’ CEO said the company has been “hampered clinically, commercially and strategically” by its prior dependence on a J&J catheter.

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 ...

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

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

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 ...

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 ...

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