Intuitive Surgical’s da Vinci robot earns FDA clearance for cardiac procedures

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Intuitive Surgical has received FDA clearance for cardiac procedures using the da Vinci 5 surgical robot, according to a Jan. 26 report from Mass Device

The new cardiac clearances cover mitral valve repair, internal mammary artery mobilization for cardiac revascularization, patent foramen ovale closure, atrial septal defect repair, left atrial appendage closure/occlusion, atrial myxoma excision, mitral valve replacement, tricuspid valve repair and epicardial pacing lead placement.

Intuitive’s portfolio of non-Force Feedback instruments all earned initial FDA approvals. The company will also look to receive cardiac clearances for its Force Feedback portfolio. 

Surgeons used the da Vinci system for about 17,000 cardiac procedures worldwide in 2025, according to Intuitive Surgical’s CFO Jamie Samath.

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