Intuitive Announces Expanded Indications for da Vinci SP

FDA clearance expands da Vinci SP indications to include inguinal hernia repair, cholecystectomy, and appendectomy

SUNNYVALE, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Intuitive (NASDAQ: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the da Vinci Single Port (SP) surgical system for use in inguinal hernia repair, cholecystectomy, and appendectomy procedures.

These clearances expand da Vinci SP’s capabilities and build on its existing U.S. clearances in urology, colorectal, thoracic and transoral procedures.

“Da Vinci SP was designed to give surgeons advanced capability through a single port, offering the precision and control needed in narrow or deep anatomical spaces,” said Iman Jeddi, PhD, Senior Vice President and General Manager, da Vinci Platforms and Product Operations at Intuitive. “This clearance is one part of our innovation pathway for SP. We continue to evolve the platform with new tools and capabilities that help teams pursue less invasive approaches and expand what’s possible with da Vinci SP.”

The da Vinci SP system enables surgeons to perform procedures through a single incision or natural orifice, offering enhanced visualization and precision. Its design supports access to anatomy by allowing surgeons to control up to three multi-jointed instruments and an articulating 3DHD endoscope through one entry point.

“Advancing da Vinci SP is part of our long-term commitment to helping improve the future of patient care — supporting approaches that are less invasive, reduce recovery time, lower the total cost of care, and create a better experience for patients as they return to their lives,” said Myriam Curet, MD, Executive Vice President and Chief Medical Officer at Intuitive. “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 500 peer-reviewed publications, supports the safety, efficacy, and outcomes associated with the da Vinci SP system. SP is also approved for use in Europe, Japan, and Korea for a range of procedures spanning multiple surgical disciplines.

Intuitive (NASDAQ: ISRG), headquartered in Sunnyvale, California, is a global leader in minimally invasive care and the pioneer of robotic 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.

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 atwww.intuitive.com.

For product intended use and/or indications for use, risks, cautions, and warnings and full prescribing information, visithttps://manuals.intuitivesurgical.com/market. For summary of the risks associated with surgery refer towww.intuitive.com/safety.