da Vinci 5 receives CE mark for use in Europe, ahead of Intuitive's own timeline

Intuitive Surgical/da Vinci 5

Intuitive's da Vinci 5 won CE mark, permitting sale in Europe for adult and child keyhole procedures in urology, gynaecology and general surgery. Company had expected European clearance near end of 2025. The system adds >150 changes vs da Vinci Xi, including force feedback to the surgeon.

• CE mark clearance for adult and paediatric use in minimal-access uro-, gynaecological and general laparoscopic surgery.
• >150 enhancements vs Xi: force feedback, 3D vision, ergonomic console optimised for surgeon career longevity.
• Accelerated timeline: achieved ahead of company guidance (expected late 2025); signals strong clinical evidence package.
• Da Vinci fleet in Europe: 410,000+ procedures in 2024 alone; cumulative 17M+ worldwide to date.