After claiming an FDA approval last year, Intuitive has obtained a greenlight in Europe for its latest surgical robot, the da Vinci 5.
The CE Mark covers adult and pediatric use spanning several endoscopic procedures, including in urology, gynecology and general laparoscopic surgery across the chest, abdomen and pelvis.
The da Vinci 5 multiport system marks Intuitive’s first to feature force feedback, which the company has said can lessen the amount of physical stress that surgeons deliver to tissue as they work.
In addition, Intuitive said the latest-generation robot adds more than 150 updates compared to its da Vinci predecessors, which were used in over 410,000 procedures across Europe in 2024, and in nearly 17 million surgeries worldwide since their debut.
“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,” Intuitive’s new CEO, Dave Rosa, said in a statement after taking the helm July 1. The company’s prior long-time chief, Gary Guthart, will serve as executive chair of Intuitive’s board.
First launched in the U.S. starting in March 2024, the da Vinci 5 also includes integrated insufflation and electrosurgical units, and comes with onboard computing power 10,000 times greater than the da Vinci Xi, which was greenlit in 2016.
Last year the company warned of potential supply constraints as the da Vinci 5’s rollout got underway, with manufacturing capacity slated to come fully online within the first half of 2025, including new production locations in Germany and Bulgaria, as well as California.
This past January—as the company evaluated the effects of new worldwide tariffs from the Trump administration—Intuitive said it placed 362 da Vinci 5 systems during the 2024 calendar year, with over 2,500 surgeons performing more than 32,000 procedures.
At the same time, Intuitive inked commercial distribution deals in Western Europe, with agreements set to close in 2026 that would see it wholly acquire the da Vinci- and Ion-related operations of ab medica, Abex, Excelencia Robotica and their affiliates, to establish direct presences in Italy, Spain, Portugal, Malta and San Marino.