FDA clears da Vinci 5 for selected thoracoscopic cardiac procedures

The FDA cleared the da Vinci 5 system through a 510(k) for selected thoracoscopically assisted cardiac procedures, including mitral valve repair and internal mammary artery mobilization. The clearance covers nine procedure types and only non-force-feedback instruments. Intuitive said a limited number of U.S. sites will start building da Vinci 5 cardiac programs with it during 2026.

• 510(k) clearance announced January 26, 2026
• Nine cardiac procedures listed, including mitral valve repair, atrial septal defect repair, left atrial appendage closure and mitral valve replacement
• Covers non-force-feedback instruments only
• A limited number of U.S. sites to start da Vinci 5 cardiac programs during 2026