Intuitive Surgical’s da Vinci SP robotic system has earned the European CE mark for transvaginal gynecologic procedures, extending its approved applications in the region. The approval comes after the company secured authorization in January 2024 to market the platform for endoscopic and thoracoscopic surgeries, marking its first major expansion since then.
This latest clearance permits surgeons to perform minimally invasive gynecologic operations through a vaginal entry point, removing the necessity for abdominal cuts. Tilman Schlick, vice president of medical affairs and medical officer at Intuitive in Europe, said in a statement that procedures covered by the new CE mark are “less invasive, scarless surgery approaches.” The approach may shorten recovery times and enhance patients’ experience as they return to their daily lives. The company had previously demonstrated the system’s advantages in abdominal surgeries, but this new indication broadens its potential impact.
Adoption of the da Vinci SP has surged in recent periods. Over the past year, the number of installed systems grew by 39% year-over-year, while the volume of procedures climbed 29%, leading to an 87% rise in total surgeries performed. In the second quarter of 2026 alone, Intuitive deployed 38 new units, up from 23 in the same quarter the previous year, raising the total installed base to 445 systems. During that same period, procedure volume increased by 61%, reflecting strong demand.
Despite its growing role, the single-port design remains a smaller segment of Intuitive’s broader portfolio. In the second quarter, these systems accounted for under 10% of all robotic placements, with multi-port models continuing to dominate the company’s surgical offerings. The da Vinci SP’s niche focus on minimal-access procedures contrasts with its more established counterparts, though it addresses unmet needs in certain specialties.
Intuitive’s latest approval builds on its 2023 introduction of a single-port robotic surgery stapler, which expanded the system’s functional range. The company has named the U.S. and Korea as growth markets for the technology. While adoption of da Vinci SP has increased in recent years, barriers to broader market penetration may include high costs and the need for specialized surgeon training.
