Intuitive, a US-based developer of minimally invasive surgical technology, has announced that its da Vinci 5 Surgical System has secured CE mark approval.
This certification allows for its use across Europe in both adult and paediatric minimally invasive procedures, encompassing endoscopic surgeries in the abdominopelvic and thoracic regions.
The system is applicable to a range of surgical areas, including urological, gynaecological, and general laparoscopic procedures.
The da Vinci 5, which represents the latest advancement in Intuitive’s robotic-assisted surgical technology, incorporates over 150 enhancements from previous models.
It is designed to improve surgical capabilities with features like Force Feedback technology, a realistic 3D vision system, and an ergonomic surgeon console. These improvements aim to increase operational efficiency with a user-friendly interface and automated task assistance.
Intuitive CEO Dave Rosa said: “At Intuitive, we’re focused on providing healthcare systems across Europe and around the world with thoughtful innovation that solves problems today and into the future.
“After over a decade of careful development, da Vinci 5 is the most advanced and integrated platform we’ve ever created – designed to enable better outcomes, efficiency, and insights for the future of minimally invasive care.”
The US Food and Drug Administration had already cleared the da Vinci 5 Surgical System in 2024 for similar applications, covering urology, general, gynaecology, and thoracic procedures.
Intuitive’s suite of surgical systems includes the multiport da Vinci X and Xi models as well as the single-port da Vinci SP system.
The da Vinci systems are engineered to assist surgeons in performing minimally invasive surgery with high-definition 3D vision and precision robotic instruments.
In May 2025, Intuitive announced that the FDA has approved the da Vinci Single Port (SP) system for performing transanal local excision/resection in colorectal procedures. This extends the system’s applications beyond those previously cleared by the FDA in November 2024.
