Intuitive Receives CE Mark Approval for da Vinci 5 Surgical System in Europe
Sunnyvale, California – Intuitive, a global leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced today that their latest surgical system, the da Vinci 5, has received CE mark approval for adult and pediatric use in Europe. This approval allows for the use of the da Vinci 5 in minimally invasive endoscopic procedures across a range of abdominal, pelvic, and thoracic surgical procedures.
The da Vinci 5 is Intuitive’s most advanced and integrated multiport surgical system, building upon the highly functional design of the da Vinci Xi. With over 150 enhancements, the da Vinci 5 joins a portfolio of surgical systems that have been used to treat over 410,000 patients in Europe in 2024 and nearly 17 million patients worldwide to date.
Intuitive’s Chief Executive Officer Dave Rosa stated, “We are pleased that our da Vinci 5 Surgical System has received CE mark approval, marking its entry to Europe. At Intuitive, we are committed to providing healthcare systems across Europe and around the world with innovative solutions that solve problems today and into the future. After over a decade of development, the da Vinci 5 is our most advanced and integrated platform yet, designed to enable better outcomes, efficiency, and insights for the future of minimally invasive care.”
The da Vinci 5 is designed to deliver enhanced surgical senses, operational efficiency, and actionable insights. These features include first-of-its-kind Force Feedback enabled technology,¹ a realistic 3D vision system,² and an ergonomic, immersive surgeon console² to help improve patient outcomes and support surgeons’ career longevity. It also offers operational efficiency through greater surgeon autonomy³ and a streamlined workflow with an easy-to-learn system and dynamic assistance to automate select tasks. Additionally, the da Vinci 5 provides surgeons with more usable data to help quantify, understand, and improve their surgical performance for patients.
Dirk Barten, Intuitive’s Senior Vice President and General Manager for Europe, 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. It’s exciting that surgeons and care teams across Europe will have their choice of the full portfolio of da Vinci systems, giving greater choice and flexibility, and ultimately supporting quality care for more patients across the region.”
In 2024, the U.S. Food and Drug Administration cleared the da Vinci 5 Surgical System for use during urology, general, gynecology, and thoracic procedures in adults. The da Vinci 5 is the fifth generation da Vinci surgical system and the latest addition to the da Vinci family, which includes multiport systems da Vinci X and da Vinci Xi, and the single-port system da Vinci SP.
2025 marks Intuitive’s 30th year developing robotic-assisted technology with the goal of improving patient outcomes, improving patient and care team experience, increasing access to minimally invasive care, and lowering the total cost to treat. In Intuitive’s first three decades, surgeons have performed nearly 17 million procedures using our technology, and nearly 90,000 surgeons have been trained to use our systems worldwide.
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 surgical system and the Ion endoluminal system. By uniting advanced systems, progressive learning, and value-enhancing services, we help physicians and their teams optimize care delivery to support the best outcomes possible. At Intuitive, we envision a future of care that is less invasive and profoundly better, where disease is identified early and treated quickly, so that patients can get back to what matters most.
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 surgical systems are designed to help surgeons perform minimally invasive surgery and offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels, and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.
About the Ion Endoluminal System
The Ion Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures.
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