Intuitive’s da Vinci SP single-port surgical system has received the European CE mark for use in gynecological procedures performed through the vagina, expanding the range of permitted uses for the device in Europe.
The update follows a previous European authorization in January 2024 that allowed the system to be marketed for use in a range of surgical procedures. The original authorization covered laparoscopic procedures in the pelvic and abdominal regions, thoracic surgeries, transoral ear, nose and throat surgeries, transanal colorectal surgeries, as well as breast surgeries.
What changed in practice?
In previous uses, physicians could insert the system through a single surgical incision or through the mouth or anus, depending on the type of operation. The new CE mark adds the possibility of accessing gynecological surgical sites through the vagina, enabling gynecological procedures through an approach that, according to the company’s description, does not leave a visible external scar.
Tilman Schlick, vice president of medical affairs and chief medical officer at Intuitive in Europe, said these procedures may reduce recovery time and improve patients’ experience as they return to their daily lives. These points remain statements from the company and are not new clinical results announced in the material.
Why does this update matter?
The approval gives the system an additional entry point into a relatively new surgical specialty within its European use portfolio and supports Intuitive’s strategy of expanding the number of procedures that can be performed using the single-port robot. This step is significant for hospitals and surgical teams evaluating technologies intended to reduce the number of incisions or avoid external scars, while the decision to use it remains linked to the specialty, approved procedures, and local clinical assessment.
The device’s growth and current limitations
The figures cited in the material indicate that the installed base of da Vinci SP systems increased 39% year over year last year, while utilization rose 29%, contributing to an 87% increase in the number of procedures. In the second quarter, Intuitive installed 38 systems of this model, compared with 23 systems in the second quarter of 2025, bringing the total installed base to 445 systems. The number of procedures in the same quarter also increased 61%.
Nevertheless, Intuitive’s multiport da Vinci system remains the foundation of the company’s business. The da Vinci SP accounted for less than 10% of the da Vinci systems Intuitive installed in the second quarter. This proportion shows that expanding indications and uses supports a growing product, but has not yet changed the commercial center of gravity of the company’s platform.
certi.news analysis: The actual change here is regulatory and practical, not the launch of a new robot; a gynecological surgical route has been added to an existing system. Open questions regarding the speed at which hospitals adopt this use, the availability of the required surgical expertise, and comparative outcomes with traditional methods remain outside the scope of the information provided by the source.