The U.S. Food and Drug Administration cleared Intuitive Surgical’s da Vinci Single Port (SP) robotic system for three new general‑surgery indications—inguinal hernia repair, cholecystectomy, and appendectomy—on December 10, 2025. The approval expands the SP platform’s clinical portfolio beyond its existing thoracic, colorectal, urology, and transoral indications and positions the system for routine use in the most common minimally invasive procedures performed each year.
The clearance is strategically significant because it unlocks a large, high‑volume market that can drive utilization of the SP system’s single‑port design. Each additional procedure performed on the platform generates revenue from disposable instruments and accessories, the core of Intuitive’s razor‑blade business model. With a global installed base of more than 10,000 da Vinci systems, the new indications are expected to translate into a measurable increase in instrument sales and recurring service revenue, reinforcing the company’s long‑term growth trajectory.
Prior to this approval, the SP system had been cleared for thoracic, colorectal, urology, and transoral procedures, all of which are performed in specialized surgical centers. The addition of general‑surgery indications broadens the platform’s appeal to community hospitals and ambulatory surgery centers, where the SP’s smaller footprint and single‑incision approach can reduce operating room time and improve workflow integration.
Intuitive’s senior product leaders highlighted the clinical benefits of the new clearance. Iman Jeddi, Senior Vice President and General Manager of da Vinci Platforms, said the SP’s single‑port design “provides surgeons with advanced capabilities in narrow or deep anatomical spaces, enabling precise, minimally invasive surgery for a broader range of patients.” Chief Medical Officer Myriam Curet added that the expansion “demonstrates Intuitive’s commitment to improving patient outcomes through less invasive approaches, faster recovery, and lower overall costs.”
The regulatory milestone is expected to accelerate adoption of the SP system in community hospitals and ambulatory centers. The single‑port design requires less operating room space and can be integrated into existing surgical workflows with minimal training, making it an attractive option for facilities that need to expand minimally invasive services without significant capital investment.
By securing FDA clearance for these high‑volume procedures, Intuitive strengthens its competitive position against rivals such as Medtronic, CMR Surgical, and Johnson & Johnson. The expanded indication list not only broadens the platform’s market reach but also deepens the company’s recurring revenue streams, reinforcing its leadership in the surgical robotics market.
In summary, the FDA clearance of the da Vinci SP for inguinal hernia repair, cholecystectomy, and appendectomy marks a key regulatory milestone that is likely to increase platform utilization, boost instrument and accessory revenue, and solidify Intuitive’s market leadership in minimally invasive surgery.
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