SUNNYVALE (California), July 2, 2025 – Intuitive is a global leader in minimally invasive surgery and the pioneer in robotic-assisted surgeries. The da Vinci 5 Surgical System received CE mark approval in Europe for adults and children for minimally invasive procedures in abdominopelvic surgery, including urologic and gynecologic procedures, general laparoscopic procedures, and thoracoscopic procedures. Da Vinci 5 is Intuitive’s most advanced and integrated robotic-assisted surgery system. It builds on the highly functional design of the da Vinci Xi Surgical System.

The system features more than 150 improvements and joins the portfolio of da Vinci systems that surgeons used to treat nearly 17 million patients globally and 410,000 patients in Europe by 2024.

Intuitive’s Chief Executive Officer Dave Rosa said, “We are delighted that our da Vinci 5 Surgical System received CE mark approval marking its entry into Europe.”

At Intuitive we are focused on providing healthcare systems in Europe and around the globe with thoughtful innovation to solve problems today and into tomorrow. Rosa said that after a decade-long development process, da Vinci 5 was the most advanced platform ever developed. It is designed to improve outcomes, efficiency and insights in the future of minimally-invasive care.

Da Vinci 5 will deliver:

• Improved surgical senses for better patient outcomes; the most realistic 3D da Vinci Vision System to date2; and an ergonomic, immersive console2 that will aid surgeons in their career longevity. Operational efficiency is achieved through greater surgeon autonomy3 and the integration of key components at the surgeon’s fingertips. Workflow is also streamlined with a system that is easy to learn, with a universal interface for care teams and with dynamic assistance integrated in the system.

• Actionable insight via an intelligent platform with 10,000x greater computing power³ as well as new sensors, advanced processors, and software. This will provide surgeons with more useful data to quantify, understand, improve, and quantify their surgical performance. “We believe the operational efficiencies, actionable insights and advanced processors provided by da Vinci 5 not only will transform surgery, but also help healthcare systems in Europe address critical challenges,” said Dirk Barten. Intuitive’s senior vice president and general manger for Europe. Barten said, “It is exciting that surgeons in Europe will be able to choose from the entire portfolio of da Vinci Systems, including da Vinci 5. This will give them greater flexibility and choice, and support quality care for many more patients throughout the region.” The U.S. Food and Drug Administration has approved the da Vinci 5 Surgical System to be used in 2024 for urology, gynaecology, thoracic and general procedures on adults.

  Da Vinci 5 represents the latest addition to da Vinci’s family and is the fifth-generation da Vinci system. This includes the multiport systems da Vinci X, da Vinci Xi and the single-port system da Vinci SP. Intuitive offers surgeons and hospitals a choice of highly capable and proven solutions.

  Intuitive will celebrate its 30th anniversary of developing robotic-assisted technologies in 2025. The company’s goal is to improve patient outcomes, increase access to minimally-invasive care, and lower the total cost of treatment. In the first three decades of Intuitive, nearly 17 million surgical procedures were performed using our technology. Nearly 90,000 surgeons worldwide have been trained on our systems.

  Notes to editors

  Contact

  For more information, please contact:

  • Jan Sciegienny, Intuitive, E: jan.sciegienny@intusurg.com M: +49 151 52393699

  About Intuitive Surgical, Inc.

  Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale, California, is a global leader in minimally invasive care and the pioneer of robotic-assisted surgery. Our technologies include the da Vinci endoluminal and surgical systems. We help physicians and their teams optimize the delivery of care by combining advanced systems, progressive training, and value-enhancing service. We envision a future where care is less invasive, more effective, and patients can focus on what’s important.

  For more information, please visit: https://www.intuitive.com/en-us

  About da Vinci surgical systems

  There are several models of the da Vinci surgical system. The da Vinci systems are designed to assist surgeons in performing minimally invasive surgeries. They offer surgeons high definition 3D vision, magnified views, robotic and computer assistance, and high-definition, 3-dimensional, 3D images. They use specialized instruments, such as a miniature surgical camera and wristed tools (such as scissors, scalpels, or forceps), that are designed to assist with precise dissection and reconstructive surgery deep inside the body.

  Ion Endoluminal System.

  Ion Endoluminal System, Model IF1000, assists the user with navigation of a catheter and other endoscopic tools within the pulmonary tract by using endoscopic visualization. The Ion Endoluminal System allows placement of fiducial markers. It is not intended for pediatric use and does not make any diagnosis. This material may contain forecasts and estimates from which actual results could differ.

  Certain products, features or technology may not be available in every country. Please contact your local representative to find out if the product is available in your area. For information on indications, contraindications and warnings, please refer to the User Manual specific to each product.

  c) 2025 Intuitive Surgical Operations, Inc., All rights reserved. Intuitive Surgical, da Vinci and Ion are trademarks and registered trademarks.

  ---

  1 The availability of Force Feedback instruments in Europe is subjected to future regulatory approval.

  1 Compared to da Vinci Xi and SP systems. Data on file with Intuitive.

  Comparing da Vinci Xi to the system. Data stored at Intuitive.