Intuitive’s da Vinci 5 Surgical Robot Approved for Use in Europe

Sunnyvale, California, July 2025 — Intuitive, a global leader in robotic-assisted surgery, has announced that its latest surgical robot, the da Vinci 5 Surgical System, has received CE Mark approval. This approval allows the use of the da Vinci 5 system for both adult and pediatric patients across Europe in a wide range of minimally invasive surgeries, including urologic, gynecologic, and general laparoscopic procedures.

This regulatory milestone follows the U.S. Food and Drug Administration’s 510(k) clearance, which was granted in March 2024 for use in adult patients in the United States. Now, with both U.S. and European approvals in hand, Intuitive is preparing for broader global deployment.

The Most Advanced da Vinci Robot to Date

The da Vinci 5 is the fifth-generation surgical robot developed by Intuitive. It builds on the design of its predecessor, the da Vinci Xi, and includes more than 150 system enhancements aimed at improving performance, workflow, and patient outcomes.

Key new features include:

Force Feedback technology that allows surgeons to feel subtle tissue resistance, reducing trauma during procedures
Next-generation 3D vision system, offering sharper and more natural visual clarity
Surgeon-friendly ergonomic console, which supports better posture and comfort
10,000 times more computing power than the previous system, allowing for deeper insights and smoother operations
Integrated OR technologies, including electrosurgical units and insufflation systems for more seamless control

According to Intuitive, these upgrades aim to improve the precision, efficiency, and insight surgeons have during operations.

Here are the capabilities:

Intuitive’s 10-Year Journey to Build Its Most Advanced Surgical Robot

Development of the da Vinci 5 system began more than ten years ago. Engineers and surgeons worked closely to design a system that responds to real-world surgical needs and helps overcome current limitations in robotic-assisted procedures.

“We are pleased that our da Vinci 5 Surgical System has received CE mark approval, marking its entry to Europe,” said Dave Rosa, CEO of Intuitive. “After over a decade of careful development, da Vinci 5 is the most advanced and integrated platform we’ve ever created. It is designed to enable better outcomes, more efficient workflows, and deeper surgical insights.”

How da Vinci 5 Will Improve Surgical Care Across European Hospitals

With this approval, hospitals across Europe can now adopt the da Vinci 5 system to support a wide range of procedures, including those performed in urology, gynecology, general surgery, and thoracic surgery.

Dirk Barten, Senior Vice President and General Manager for Europe at Intuitive, emphasized the system’s value:
“We believe the operational efficiencies and actionable insights provided by da Vinci 5 will not only help transform surgery but also help address critical challenges faced by healthcare systems across Europe.”

European hospitals will now have access to the full portfolio of da Vinci systems — including da Vinci X, da Vinci Xi, da Vinci SP, and now da Vinci 5 — allowing care teams to choose the system that best fits their needs.

Expected Impact of da Vinci 5 on Global Surgeries and What Lies Ahead

In 2024 alone, surgeons performed over 410,000 procedures using da Vinci systems across Europe, and nearly 17 million surgeries worldwide since the platform’s debut. The CE Mark approval is expected to increase these numbers significantly in the coming years.

Intuitive has also begun expanding its manufacturing capacity to meet growing demand. New production facilities in Germany, Bulgaria, and California are expected to come fully online during the first half of 2025.

In addition, Intuitive has entered commercial distribution agreements in Western Europe to gain a direct presence in countries like Italy, Spain, Portugal, and Malta by 2026.

Robotic Surgery's Role in the Future of Healthcare

According to projections from NHS England, robotic-assisted surgeries will continue to grow. The number of such procedures is expected to rise from 70,000 in 2023 to 500,000 annually by 2035. Within a decade, nine out of ten keyhole surgeries are expected to use robotic assistance.

The launch of da Vinci 5 represents an important step toward making robotic surgery the standard of care across many surgical fields.

Final words

The CE Mark approval of da Vinci 5 is a major achievement for Intuitive and for robotic surgery as a whole. With cutting-edge features, real-time data insights, and surgeon-friendly design, this new system aims to make surgery safer, faster, and more precise.

By expanding its presence in Europe and beyond, Intuitive is moving closer to its long-term vision: a future where minimally invasive care is more accessible, more effective, and powered by intelligent robotic technology.