Medtronic has received clearance from the U.S. Food and Drug Administration for its Hugo robotic-assisted surgery (RAS) system for use in urologic procedures, the company announced this week.

The Galway, Ireland-based medical device manufacturer said the Hugo system is now approved for minimally invasive surgeries such as prostatectomy, nephrectomy, and cystectomy. These three procedures account for an estimated 230,000 cases annually in the United States.

With the clearance, Medtronic enters the U.S. soft-tissue robotic surgery market with a modular system that it says offers flexibility in configuration and integration with digital tools. The company expects to expand indications to general and gynecologic procedures following this initial approval.
“This is an incredibly exciting day for healthcare in the United States,” said Rajit Kamal, vice president and general manager of robotic surgical technologies at Medtronic. “FDA clearance of the Hugo RAS system means there is now choice for hospitals looking to expand their robotic programs and increases access for patients.”

The Hugo platform includes a modular arm design that allows for more adaptable use across care settings, as well as an open console intended to improve surgeon ergonomics and team communication. The system also connects to the company’s Touch Surgery platform, providing case review tools, tele-mentoring, and AI-based analytics.

The FDA’s decision follows data from the company’s Expand URO study, which Medtronic says is the largest U.S. trial conducted for multiport robotic-assisted urologic surgery. According to the company, the study met primary safety and efficacy endpoints with results consistent with existing literature.

The Hugo system has already been deployed internationally in more than 30 countries across five continents, with use reported in tens of thousands of procedures. Medtronic said it plans a phased U.S. rollout and is positioning the system as part of a broader connected surgical offering.

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