Intuitive wins Europe CE mark to expand da Vinci SP into transvaginal gynecologic surgery
Intuitive Surgical said European regulators granted a CE mark expanding its da Vinci SP (Single Port) robotic system to cover transvaginal gynecologic procedures, and the company frames that as the first such indication for SP on top of existing European approvals for other endoscopic and natural-orifice routes.
Europe just cleared a new natural-orifice route for Intuitive’s single-port robot — a concrete regulatory step for less-invasive women’s surgery, not another AI chatbot press release.
Intuitive, the California surgical-robot company, said via PR Newswire from its European headquarters in Aubonne, Switzerland, that it received a CE mark expanding the da Vinci SP — Single Port — system to transvaginal gynecologic procedures. A CE mark is Europe’s safety stamp that lets a medical device be sold in the European Economic Area. Gynecologic means surgery on the female reproductive system. Transvaginal means the surgeon works through the vagina, a natural opening, instead of cutting through the abdomen. That company release, dated 14 Sep 2026 at 02:00 ET, is the filing event.
The company calls this a world’s-first indication for the SP system.
Intuitive says the new indication expands SP’s already CE-marked uses in Europe: endoscopic abdominopelvic (camera-and-tools work in the belly and pelvis), thoracoscopic (the same idea in the chest), transoral otolaryngology (through the mouth, for ear-nose-throat), transanal colorectal (through the anus, for the bowel), and breast surgery.
SP, as Intuitive describes it, lets a surgeon work through one incision or a natural orifice — a body opening that already exists. Through that single entry, the surgeon can control up to three multi-jointed instruments plus a fully articulating 3DHD endoscope, a high-definition 3D camera on a bending arm.
Dirk Barten, Intuitive’s commercial president for Europe, said the approval builds on SP use in women’s health and 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.” “Potentially” is his word.
Tilman Schlick, vice president of medical affairs and medical officer for Intuitive in Europe, said transvaginal procedures expand SP’s natural-orifice portfolio, which already includes transoral and transanal work. Quoted: “These less invasive, scarless surgery approaches have the potential to shorten recovery times and enhance patients’ experience as they return to their daily lives.” This is not an outcomes study from this desk.
Intuitive cites more than 1,000 peer-reviewed publications on the safety, efficacy, and patient outcomes of the da Vinci SP system. That count is the company’s claim.
The company says SP is also approved for use in the United States, Japan, and Korea for a range of procedures.