Dive Brief:
- Intuitive Surgical on Wednesday said its da Vinci 5 robot received CE mark approval for adult and pediatric use in Europe across multiple minimally invasive procedures, including urologic, gynecologic and general laparoscopic.
- The European clearance for da Vinci 5 comes ahead of the company’s projections. CEO Dave Rosa, who took the helm on July 1 from Gary Guthart, said on an earnings call in April that clearance for da Vinci 5 in Europe was expected near the end of 2025.
- The fifth generation system is the robotic surgery pioneer’s most advanced, with updates such as force feedback technology, an enhanced vision system and more computing power that are designed to improve patient outcomes and operational efficiency.
Dive Insight:
Da Vinci 5 enters the European market following the system’s closely watched U.S. debut in early 2024. Intuitive is continuing to expand its launch of the system in the U.S., where it is cleared for use in urology, general, gynecology and thoracic procedures in adults.
Rosa, on the April call, said Intuitive was ramping manufacturing operations and supply chain capabilities to support the broad launch of da Vinci 5 at midyear. The broad launch involves fully integrating the company’s latest hardware and software and meeting customer demand, including trade-ins and dual consoles, Rosa said.
The limited rollout of da Vinci 5 has gone faster than expected, driving strong system placements for the company in 2024.
In Europe, surgeons used da Vinci surgical systems in more than 410,000 procedures last year. The platform has supported nearly 17 million procedures worldwide to date, Intuitive said.
The European clearance comes as Intuitive prepares for increased competition in the soft tissue robotics market, with newcomers such as Moon Surgical and CMR Surgical gearing up to bring systems to the U.S. market and larger competitor Medtronic eyeing a Food and Drug Administration approval.
