Intuitive Receives CE Mark Approval for da Vinci 5 Surgical System
SUNNYVALE, California, July 2, 2025 – Intuitive, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced today that their da Vinci 5 Surgical System has received CE mark approval for adult and pediatric use in Europe.
The CE mark approval allows for the use of this advanced surgical system in minimally invasive endoscopic procedures across abdominopelvic and thoracoscopic surgical procedures. This includes urologic, gynecologic, and general laparoscopic procedures, providing surgeons with a versatile tool for various surgeries.
Intuitive’s CEO Dave Rosa expressed his pleasure with the approval, stating, “We are pleased that our da Vinci 5 Surgical System has received CE mark approval, marking its entry to Europe. At Intuitive, we are dedicated to providing healthcare systems across Europe and around the world with innovative technology that not only solves current problems but also prepares for the future. The da Vinci 5 is the most advanced and integrated platform we have ever created, designed to improve patient outcomes, efficiency, and insights for minimally invasive care.”
The da Vinci 5 Surgical System is designed to provide surgeons with enhanced surgical senses, operational efficiency, and actionable insights. With more than 150 enhancements, it offers a realistic 3D vision system, ergonomic surgeon console, and first-of-its-kind Force Feedback enabled technology. This, along with its streamlined workflow and dynamic assistance, aims to improve patient outcomes and support surgeons in their careers.
Dirk Barten, senior vice president and general manager for Europe at Intuitive, believes that the da Vinci 5 will not only transform surgery but also address critical challenges faced by healthcare systems in Europe. He stated, “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.”
The da Vinci 5 Surgical System is the latest addition to the da Vinci family, which includes the da Vinci X, Xi, and SP systems. These systems have been used to treat over 410,000 patients in Europe in 2024 and nearly 17 million patients worldwide to date. With the addition of the da Vinci 5, surgeons and hospitals now have a choice of highly capable and proven solutions from Intuitive.
Intuitive is celebrating its 30th year of developing robotic-assisted technology, with the goal of improving patient outcomes, care team experience, and access to minimally invasive care while lowering the total cost to treat. In this time, nearly 90,000 surgeons have been trained to use their systems worldwide, and they have performed nearly 17 million procedures.
For more information on the da Vinci surgical systems, please visit https://www.intuitive.com/en-us.
Note to editors: For more information, please contact Jan Sciegienny, Intuitive, at jan.sciegienny@intusurg.com or +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. Their technologies include the da Vinci surgical system and the Ion endoluminal system. With a focus on optimizing care delivery, they offer physicians and their teams advanced systems, progressive learning, and value-enhancing services. Their vision is a future of care that is less invasive and profoundly better, with early identification and quick treatment of diseases, allowing patients to return to their daily lives.
For more information, please visit https://www.intuitive.com/en-us.
About the da Vinci surgical systems
The da Vinci surgical systems are designed to assist surgeons in performing minimally invasive surgery. They offer high-definition 3D vision, a magnified view, and robotic and computer assistance. With specialized instrumentation including a miniaturized surgical camera and wristed instruments, surgeons can perform precise dissection and reconstruction deep inside the body.
About the Ion Endoluminal System
The Ion Endoluminal System (Model IF1000) assists with navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree. It also enables fiducial marker placement and is not intended for pediatric use.
This material may contain estimates and forecasts from which actual results may differ.
Some products, features, or technologies may not be available in all countries. Please contact your local Intuitive representative for product availability in your region. Please refer to the product-specific User Manual for indications, contraindications, warnings, and other product information.
© 2025 Intuitive Surgical Operations, Inc. All rights reserved. Product and brand names/logos, including Intuitive, da Vinci, and Ion, are trademarks or registered trademarks of Intuitive Surgical or their respective owners.
¹ Availability of