Intuitive’s da Vinci 5 Surgical System Receives CE Mark

Rhea-AI Summary

Intuitive (NASDAQ:ISRG) has received CE mark approval for its da Vinci 5 Surgical System in Europe, marking a significant milestone for the company's most advanced robotic-assisted surgical platform. The system is approved for both adult and pediatric use across abdominopelvic and thoracoscopic procedures.

The fifth-generation system features over 150 enhancements, including Force Feedback technology, an improved 3D vision system, and 10,000x more computing power. The platform has already received FDA clearance in 2024 for various procedures and joins Intuitive's portfolio of surgical systems that have been used in over 410,000 procedures in Europe in 2024 and nearly 17 million procedures worldwide.

Positive

• CE mark approval expands market access to Europe for da Vinci 5 system
• System features revolutionary Force Feedback technology and enhanced 3D vision
• Platform offers 10,000x more computing power for improved surgical insights
• Builds on strong market presence with 410,000+ European procedures in 2024
• System approved for both adult and pediatric use across multiple procedure types

Negative

• Extensive development period of over a decade indicates significant R&D investment
• Will compete with existing da Vinci product line potentially causing cannibalization

Insights

Medical Technology Analyst

Intuitive's CE Mark for da Vinci 5 expands market reach in Europe, driving potential revenue growth through its most advanced surgical system.

Intuitive's announcement of CE mark approval for its da Vinci 5 Surgical System represents a significant commercial milestone for the company's European expansion strategy. The approval covers both adult and pediatric use across multiple procedure types including urologic, gynecologic, general laparoscopic, abdominopelvic, and thoracoscopic surgeries.

The da Vinci 5 builds upon Intuitive's established Xi platform with over 150 enhancements, positioning it as the company's most advanced multiport robotic system to date. What makes this system particularly noteworthy is the integration of Force Feedback technology - a first-of-its-kind feature that provides tactile sensation to surgeons, addressing one of the historical limitations of robotic surgery.

From a market perspective, the timing is strategic. Europe represents a substantial portion of Intuitive's global footprint, with over 410,000 procedures performed in 2024 alone. The company now offers European healthcare providers a complete portfolio including multiport systems (da Vinci X, Xi, and 5) and the single-port da Vinci SP, allowing for market segmentation strategies based on procedural needs and budget considerations.

The system's 10,000x increase in computing power and advanced sensors reflect Intuitive's focus on data-driven surgery. This computational leap enables real-time analytics and potential procedure optimization, which could translate to clinical outcome improvements and operational efficiencies for hospitals - important selling points in Europe's value-based healthcare systems.

For context, this approval follows the system's 2024 FDA clearance in the US, creating a synchronized global rollout strategy across major markets. As Intuitive celebrates its 30th year, this approval reinforces their dominant position in surgical robotics with nearly 17 million procedures performed worldwide using their technology and approximately 90,000 trained surgeons globally.

Fifth-generation da Vinci surgical system approved for use in Europe across multiple procedures

SUNNYVALE, Calif., July 02, 2025 (GLOBE NEWSWIRE) -- Intuitive (NASDAQ:ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced today that the da Vinci 5 Surgical System has received CE mark approval for adult and pediatric use in Europe for minimally invasive endoscopic procedures across abdominopelvic and thoracoscopic surgical procedures, including urologic, gynecologic, and general laparoscopic procedures.

Da Vinci 5 is Intuitive’s most advanced and integrated multiport robotic-assisted surgical system, building on the da Vinci Xi Surgical System’s highly functional design.

It features more than 150 enhancements and joins a portfolio of da Vinci surgical systems that surgeons have used in more than 410,000 procedures in Europe in 2024 and nearly 17 million procedures worldwide to date.

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

“At Intuitive, we’re focused on providing healthcare systems across Europe and around the world with thoughtful innovation that solves problems today and into the future.  After over a decade of careful development, da Vinci 5 is the most advanced and integrated platform we’ve ever created – designed to enable better outcomes, efficiency, and insights for the future of minimally invasive care,” said Rosa.

Da Vinci 5 is designed to deliver:

• Enhanced surgical senses to support better patient outcomes, including first-of-its-kind Force Feedback enabled technology, the most realistic 3D da Vinci vision system to date, and an ergonomic, immersive surgeon console to support surgeon career longevity.
• Operational efficiency, through greater surgeon autonomy with the integration of key components that surgeons can control at their fingertips, and by streamlining workflow with an easy-to-learn system, a universal user interface for care teams, and dynamic assistance integrated into the system to automate select tasks.
• Actionable insights through an intelligent platform with 10,000x more computing power and new sensors, software, and advanced processors – providing surgeons with more useable data to help them quantify, understand, and improve their surgical performance for patients.
  

“We believe that 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,” said Dirk Barten, Intuitive senior vice president and general manager for Europe.

“It's exciting that surgeons and care teams across Europe will have their choice of the full portfolio of da Vinci systems, including da Vinci 5, giving them greater choice and flexibility, and ultimately supporting quality care for more patients across the region,” said Barten.

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.

Da Vinci 5 is the fifth generation da Vinci surgical system and the latest addition to the da Vinci family. This includes multiport systems da Vinci X and da Vinci Xi, and the single port system da Vinci SP, offering surgeons and hospitals their choice of highly capable, proven solutions from Intuitive.

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 
Megan Elliott, Intuitive
(669) 222-9899
megan.elliott@intusurg.com

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: http://www.intuitive.com/safety

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 specialised instrumentation, including a miniaturised 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.

Forward-Looking Statements
This press release contains forward-looking statements which relate to expectations concerning matters that are not historical facts. Statements using words such as “estimates,” “projects,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” “can,” “could,” “should,” “would,” “targeted,” “potential,” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements are necessarily estimates reflecting the judgment of Intuitive’s management and involve a number of risks and uncertainties that could cause actual results or impacts on its operations, financial performance, and business position to differ materially from those suggested by the forward-looking statements. These forward-looking statements include, but are not limited to, statements related to research and development of products and services, manufacturing of products, obtaining of regulatory approvals, technical, clinical, and other performance of products and services, and making products and services available to more patients and health care professionals. These forward-looking statements should be considered in light of various important factors and involve known and unknown risks, uncertainties, and other factors, which may cause the actual results, performance, or achievements of Intuitive, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements include, among others, economic conditions in the geographic markets in which we operate, changes in governmental regulations, regulatory approval priorities, resources, and timelines, regulatory enforcement priorities, governmental investigations and civil litigation, and other factors discussed in Intuitive’s Annual Reports and other filings with relevant securities regulators.

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release and which are based on current expectations and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those risk factors identified under the heading “Risk Factors” in Intuitive’s Annual Report on Form 10-K for the year ended December 31, 2024, as updated by its other filings with the U.S. Securities and Exchange Commission. Intuitive’s actual results may differ materially and adversely from those expressed in any forward-looking statements, and it undertakes no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.

FAQ

What new features does the Intuitive (ISRG) da Vinci 5 Surgical System include?

The da Vinci 5 includes Force Feedback technology, the most advanced 3D vision system to date, 10,000x more computing power, and over 150 total enhancements designed to improve surgical outcomes and efficiency.

When did Intuitive's da Vinci 5 receive FDA clearance?

The da Vinci 5 Surgical System received FDA clearance in 2024 for use during urology, general, gynecology, and thoracic procedures in adults.

How many procedures have been performed using Intuitive's da Vinci systems?

Intuitive's da Vinci systems have been used in nearly 17 million procedures worldwide and over 410,000 procedures in Europe in 2024 alone.

What types of procedures is the da Vinci 5 approved for in Europe?

The system is approved for adult and pediatric minimally invasive endoscopic procedures across abdominopelvic and thoracoscopic surgical procedures, including urologic, gynecologic, and general laparoscopic procedures.

How many surgeons are trained on Intuitive's surgical systems?

Nearly 90,000 surgeons worldwide have been trained to use Intuitive's surgical systems.