Intuitive Surgical has secured CE mark approval for its da Vinci 5 surgical robot, allowing it to be marketed and used in the European Union.
Intuitive Surgical's da Vinci 5 robot, the company's most advanced system, has received CE mark approval for adult and pediatric use in Europe. This approval allows the robot to be used for multiple minimally invasive procedures, including urologic, gynecologic, and general laparoscopic procedures.
The European clearance for da Vinci 5 comes as Intuitive Surgical prepares for increased competition in the soft tissue robotics market. Newcomers like Moon Surgical and CMR Surgical are preparing to enter the U.S. market, posing a challenge to Intuitive's dominance in the field. Larger competitor Medtronic is also aiming for Food and Drug Administration (FDA) approval for its Hugo robotic-assisted surgery system, which has already been approved for use in Europe, Canada, and Japan.
The da Vinci 5 robot features force feedback technology, an enhanced vision system, and more computing power, all designed to improve patient outcomes and operational efficiency. The limited rollout of da Vinci 5 in the U.S. has gone faster than expected, driving strong system placements for the company in 2024.
The European clearance for da Vinci 5 came ahead of the company's projections, and Rosa, the new CEO, initially expected the clearance for da Vinci 5 in Europe to be near the end of 2025. However, the company is ramping up manufacturing operations and supply chain capabilities to support the broad launch of da Vinci 5 at midyear.
Globally, da Vinci surgical systems have supported nearly 17 million procedures to date. In Europe alone, more than 410,000 surgical procedures were performed last year using da Vinci surgical systems. Intuitive is continuing to expand the launch of da Vinci 5 in the U.S., where it is cleared for use in multiple specialties, including urology, general, gynecology, and thoracic procedures in adults.
Medtronic's Hugo system is expected to receive FDA approval in the United States in the second half of 2025, specifically for urologic indications. This approval would mark a significant milestone as it introduces serious competition to Intuitive Surgical’s dominant da Vinci system in the U.S. robotic surgery market. The Hugo system has already shown strong clinical results with a 98.5% surgical success rate in the Expand URO trial.
Medtronic is also running trials to expand Hugo's indications to include gynecologic and hernia procedures, aiming to broaden its market presence post-approval. The system's modular and cost-effective design, along with integration with Medtronic’s energy tools, positions it as a flexible and potentially more affordable alternative in the robotic surgery field.
[1] Medtronic Press Release: Medtronic Announces Hugo RAS Submission for U.S. FDA Review (https://www.medtronic.com/us-en/about-medtronic/news/press-releases/2023/01/medtronic-announces-hugo-ras-submission-for-us-fda-review.html)
[2] Medtronic Press Release: Medtronic Announces Hugo RAS CE Mark Approval (https://www.medtronic.com/us-en/about-medtronic/news/press-releases/2022/05/medtronic-announces-hugo-ras-ce-mark-approval.html)
[3] Intuitive Surgical Press Release: Intuitive Surgical Announces Da Vinci 5 System CE Mark Approval in Europe (https://investor.intusurg.com/news-releases/news-release-details/intuitive-surgical-announces-da-vinci-5-system-ce-mark)
[4] Medtronic Hugo RAS: Product Information (https://www.medtronic.com/us-en/product-catalog/surgical-innovations/robotic-assisted-surgery/hugo-robotic-assisted-surgery-system.html)
- The European clearance for Intuitive Surgical's da Vinci 5 robot, a device featuring force feedback technology and enhanced vision system, has been accelerated, allowing it to be used for multiple procedures in Europe.
- This AI-driven medtech innovation has already supported nearly 17 million procedures globally, with over 410,000 surgical procedures being performed in Europe last year alone.
- The da Vinci 5 robot's earnings have shown significant growth, with a limited rollout in the U.S. driving strong system placements for the company in 2024.
- As a result, Intuitive Surgical is ramping up manufacturing operations and supply chain capabilities to support the broad launch of da Vinci 5 in the international markets.
- Meanwhile, larger competitor Medtronic is also aiming for FDA approval for its Hugo robotic-assisted surgery system, which has already shown strong clinical results.
- The news of increased competition in the soft tissue robotics market follows Intuitive Surgical's CE mark approval for da Vinci 5, allowing it to be used for procedures in urology, general, gynecology, and thoracic fields.
- With the impending FDA approval for Medtronic's Hugo system expected in the second half of 2025, trends in health-and-wellness and medical-conditions may see a shift, as the system offers a potential, more affordable alternative in the robotic surgery field, positioning itself to broaden its market presence post-approval.
