Intuitive’s da Vinci 5 surgical system receives CE mark approval

Intuitive has announced that its da Vinci 5 Surgical System has received CE Mark approval for adult and paediatric use in Europe for minimally invasive endoscopic procedures across abdominopelvic surgical procedures.

This includes urologic, gynaecologic and general laparoscopic surgical procedures, and thoracoscopic surgical procedures.

Dave Rosa, chief executive at Intuitive, said: “We are pleased that our da Vinci 5 Surgical System has received CE mark approval, marking its entry to Europe.

“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 da Vinci 5 system is Intuitive‘s most advanced and integrated robotic-assisted surgical system, building on the da Vinci Xi Surgical System’s highly functional design.

It features more than 150 enhancements and joins a portfolio of da Vinci system that surgeons use to treat, according to Intuitive, more than 410,000 patients in Europe in 2024 and nearly 17 million patients worldwide to date.

The robot is designed to deliver enhanced surgical senses to support better patient outcomes, including Force Feedback enabled technology, the most realistic 3D da Vinci vision system to date, and an ergonomic, immersive surgeon console.

It is hoped that da Vinci 5 will also deliver operational efficiency through greater surgeon autonomy, with the integration of key components that surgeons can control at their fingers, and actionable insights through an intelligent platform with 10,000x more computing power.

Dirk Barten, senior vice president and general manager for Europe at Intuitive, said: “We believe that the operational efficiencies and actionable insights provided by da Vinci 5 will not only transform surgery but also help address critical challenges faced by healthcare systems across Europe.

“It’s exciting that surgeons and care teams across Europe will have their choice of the full portfolio of da Vinci systems, including da Vinci 5, giving greater choice and flexibility, and ultimately supporting quality care for more patients across the region.”

Da Vinci 5 is the fifth generation da Vinci surgical robot, following systems such as da Vinci X and da Vinci Xi, and the single port system da Vinci SP, which received CE mark approval in January 2024.

In April 2025, Cromwell Hospital in London confirmed it had successfully performed gynaecology and Hepato Pancreato Biliary (HPB) operations using da Vinci SP.

NHS England has projected that half a million operations will be supported by robotic surgery every year by 2035, up from 70,000 in 2023/24.

In a press release, NHSE said that nine in 10 keyhole surgeries, such as the removal of certain organs affected by cancer, will be delivered with robot assistance within the next 10 years, up from one in five today, with robotic surgery being the default for many operations.