Intuitive won a CE mark for adult cardiac surgery with the da Vinci 5. The clearance covers coronary artery bypass grafting, mitral and tricuspid valve repair, mitral valve replacement and left atrial appendage closure. Surgeons work through small incisions instead of opening the breastbone.
FDA cleared nine cardiac procedures for the system in the US on January 26, including mitral repair and replacement, tricuspid repair, IMA mobilization for revascularization, patent foramen ovale closure, atrial septal defect repair, left atrial appendage occlusion, atrial myxoma excision and epicardial pacing lead placement. Europe gets a comparable list along with new class III cardiac instruments.
Intuitive plans to start with a limited number of European centers in 2026 and beyond. Dirk Barten, its commercial president for Europe, called the clearance a commitment to bring robotic-assisted minimally invasive cardiac procedures back to the region. The first da Vinci cardiac cases ran in France and Germany in 1998, and limits on those earlier platforms pushed the company away from the specialty for years.
For anyone building cardiac robotics behind Intuitive, the class III instrument set is the part worth reading twice. Under MDR those instruments carry their own conformity route, and that is usually the slow lane.