News/Regulation/Sep 25, 2026

da Vinci 5 receives CE mark for adult cardiac surgery in Europe

The da Vinci 5 system has received a CE mark for adult cardiac surgery in Europe, including coronary artery bypass procedures, according to trade press reporting on September 25, 2026. Intuitive says it will add cardiac instruments, partner with a limited number of European centers to set up repeatable programs, and work with cardiac societies on training. The approval gives the newest da Vinci a second major region for cardiac work after the January 2026 FDA clearance.

  • CE mark covers adult cardiac surgery, including coronary artery bypass
  • Plans new cardiac instruments and dedicated customer infrastructure
  • Will partner with a limited number of European centers
  • U.S. cardiac clearance for da Vinci 5 came in January 2026
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Source
MedTech Dive
Sep 25, 2026
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