CE mark for transvaginal gynecologic procedures expands SP's applications

AUBONNE, Switzerland, Sept. 14, 2026 /PRNewswire/ -- Intuitive, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced CE mark approval for the indication of transvaginal gynecologic procedures for the da Vinci SP (Single Port) surgical system – marking a world's-first indication for the SP system.

This approval expands da Vinci SP's CE-marked applications in Europe, which currently include endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast surgical procedures.

"Building on the strong adoption of da Vinci SP in women's health, this approval is a meaningful step forward, not just as a regulatory milestone, but because it expands access to less invasive options for women across Europe and opens the door to potentially better recovery experiences and outcomes," said Dirk Barten, Intuitive commercial president for Europe.

The da Vinci SP system enables surgeons to perform procedures through a single incision or natural orifice, offering enhanced visualization and precision in narrow or deep anatomical spaces. Through a single-entry point, surgeons can control up to three multi-jointed instruments and a fully articulating 3DHD endoscope, enabling access to complex anatomy with minimal disruption to surrounding tissue.

"Transvaginal procedures expand the natural orifice surgery portfolio of the da Vinci SP System, which to this day includes successful transoral and transanal procedures," said Tilman Schlick, vice president, medical affairs & medical officer at Intuitive in Europe. "These less invasive, scarless surgery approaches have the potential to shorten recovery times and enhance patients' experience as they return to their daily lives. As we continue to innovate across our platforms, we remain focused on helping more patients access the benefits of minimally invasive care."

A growing body of evidence, including more than 1,000 peer-reviewed publications, supports the safety, efficacy, and patient outcomes associated with the da Vinci SP system. Da Vinci SP is also approved for use in the US, Japan, and Korea for a range of procedures spanning multiple surgical disciplines.

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About Intuitive
Intuitive (NASDAQ:ISRG), headquartered in Sunnyvale, California, with European headquarters in Aubonne, Switzerland, 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.

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.

For more information, please visit the company's website at www.intuitive.com/en-gb

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. Refer to the product specific User Manual for indications, contraindications, warnings and other product information.

© 2026 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 owner. See intuitive.com/trademarks.

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