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Intuitive's da Vinci 5 Surgical System Receives CE Mark

1. Intuitive's da Vinci 5 Surgical System received CE mark for European use. 2. System allows for adult and pediatric minimally invasive procedures. 3. Over 150 enhancements included to improve surgical outcomes and efficiency. 4. It marks Intuitive's 30th year in robotic-assisted surgery innovation. 5. Surgeons performed 410,000 procedures with da Vinci systems in Europe in 2024.

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Why Very Bullish?

The CE mark approval enhances ISRG's market position, possibly boosting sales. Historical similar approvals often led to stock price increases.

How important is it?

The approval is crucial for ISRG to expand its market footprint, likely influencing investor confidence and long-term revenue streams.

Why Long Term?

The long-term growth potential from expanded market access in Europe should uplift ISRG's performance over time, similar to trends observed post previous product launches.

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Fifth-generation da Vinci surgical system approved for use in Europe across multiple procedures July 02, 2025 09:46 ET  | Source: Intuitive Surgical, Inc. 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) 222-9899megan.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 systemsThere 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 StatementsThis 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.

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