Aubonne – September 16, 2026 -- Intuitive has secured CE mark approval for its da Vinci SP surgical system to perform transvaginal gynecologic procedures, marking the first such indication for the Single Port platform anywhere in the world.
Approval widens da Vinci SP's European surgical scope beyond five existing categories
The new indication adds to da Vinci SP's current CE-marked applications in Europe, which cover endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast procedures. The system now supports natural orifice surgery across transoral, transanal, and transvaginal routes.
Single-port design allows surgeons to operate through one incision or natural orifice
Da Vinci SP lets surgeons control up to three multi-jointed instruments and a fully articulating 3DHD endoscope through a single entry point, targeting narrow or deep anatomical spaces while limiting disruption to surrounding tissue.
Clinical evidence base exceeds 1,000 peer-reviewed publications on the platform
Intuitive cites more than 1,000 peer-reviewed studies supporting the safety and efficacy of da Vinci SP. The system already holds regulatory clearance for multiple surgical disciplines in the United States, Japan, and South Korea.
Intuitive executives frame approval as expanding less invasive care access for women
Dirk Barten, Intuitive's commercial president for Europe, said the approval builds on strong adoption of da Vinci SP in women's health and expands access to less invasive surgical options across the region. Tilman Schlick, vice president of medical affairs and medical officer for Intuitive in Europe, said the transvaginal indication extends the SP system's natural orifice portfolio and could shorten recovery times for patients.