Medtronic Secures FDA Clearance for Hugo Robotic System in Urologic Surgery
Medtronic has received the U.S. Food and Drug Administration (FDA) clearance of the Hugo™ robotic-assisted surgery (RAS) system for use in urologic surgical procedures, including prostatectomy, nephrectomy, and cystectomy — common procedures that account for about 230,000 surgeries per year in the U.S. The clearance brings a versatile robotic-assisted platform to U.S. surgeons and health systems seeking to expand soft-tissue robotic surgery programs and access to minimally invasive care.
“FDA clearance of the Hugo RAS system means there is now a choice for hospitals looking to expand their robotic programs and increases access for patients,” said Rajit Kamal, vice president and general manager of Robotic Surgical Technologies at Medtronic, which will begin a phased launch focused on establishing long-term partnerships with leading hospitals.
The Hugo system features a modular architecture that allows surgical teams to position and move robotic arms independently, with the goal of improving flexibility and operating room utilization. Medtronic designed the open surgeon console to reduce physical strain and support improved communication with bedside staff. The platform also integrates with the company’s Touch Surgery digital ecosystem, which offers training tools, remote case support, and AI-based insights from surgical video.
Dr. James Porter, a urologic surgeon and chief medical officer for Robotic Surgical Technologies and Digital Technologies, said the system introduces “a new and exciting approach to robotic-assisted surgery,” noting its potential to support surgical teams through each stage of adoption. The system is cleared for prostatectomy, nephrectomy, and cystectomy, procedures that represent roughly 230,000 urologic surgeries each year in the U.S.
FDA clearance follows results from the Expand URO clinical study, the largest U.S. investigational study of a multi-port robotic system in urology. The trial showed the system met primary safety and effectiveness endpoints with outcomes consistent with current literature. The Hugo system has already been used for tens of thousands of procedures in more than 30 countries, and Medtronic plans to pursue additional U.S. indications in general and gynecologic surgery.
