FDA grants clearance to Hugo robotic-assisted surgery system for urologic procedures

On December 3, 2025, the FDA granted clearance to the Hugo robotic-assisted surgery (RAS) system for use in minimally invasive urologic surgical procedures including prostatectomy, nephrectomy, and cystectomy, Medtronic announced in a news release.¹

"The Hugo RAS system represents a new and exciting approach to robotic-assisted surgery," said James R. Porter, MD, a urologic surgeon and chief medical officer for Robotic Surgical Technologies and Digital Technologies within the Surgical business at Medtronic, in the news release.¹ "We're excited for surgical teams in the US to experience the differentiated technology and partnership from Medtronic, which supports them at every stage of their robotic surgical journey."

The safety and efficacy of the Hugo RAS system was established in the Expand URO IDE study (NCT05696444), which was presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.² Overall, the trial met its primary efficacy and safety end points, supporting its use in patients undergoing urologic procedures.

The study enrolled a total of 137 patients who underwent a urologic procedure with the Hugo RAS system. Of these, 55 underwent prostatectomy, 29 underwent cystectomy, and 53 underwent partial (n = 36) or radical (n = 17) nephrectomy. The average age of participants was 63 years.

The primary effectiveness end point for the study was surgical success rate, defined as no conversion (the case did not switch to another FDA-cleared robot-assisted device, laparoscopy, or open surgery following the first incision). The primary safety end point was the rate of patients with grade 3 or higher Clavien-Dindo complications from incision to 30 days following surgery.

Overall, the trial met its primary end points. The surgical success rate was 98.5% (95% CI, 94.8% to 99.8%), which exceeded the performance goal of 85% (P < .0001). The were a total of 2 conversions, both of which occurred in the renal cohort.

The study also met its safety end point, demonstrating low rates of grade 3 or higher Clavien-Dindo complications across all 3 procedures. Specifically, the rate of grade 3 or higher complications was 3.7% (95% CI, 0.5% to 12.7%; P = .0006) in the prostatectomy arm, 17.9% (95% CI, 6.1% to 36.9%; P = .0025) in the cystectomy arm, and 1.9% (95% CI, 0.0% to 10.3%; P = .0001) in the nephrectomy arm, all which fell below their performance goals of 20%, 45%, and 20%, respectively.

There were 2 deaths in the study; 1 occurred in the radical prostatectomy arm and 1 occurred in the radical cystectomy arm. Both were determined to be unrelated to the study by the Independent Data Monitoring Committee.

In addition to the new urologic indication, Medtronic also announced plans to expand the Hugo RAS system’s use in the US, with expected submissions for indications in general and gynecologic surgical procedures to follow.

"This is an incredibly exciting day for health care in the United States. 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," said Rajit Kamal, vice president and general manager of Robotic Surgical Technologies within the Surgical business of Medtronic, in the news release.¹ "As we begin our purposeful launch of the Hugo RAS system in the U.S., our focus is on building a strong foundation with leading hospitals through our differentiated approach to partnership, rooted in our enduring commitment to provide an excellent customer experience and enable surgical teams to deliver the best possible outcomes for their patients."

REFERENCES

1. Medtronic announces FDA clearance of Hugo™ robotic-assisted surgery system for urologic surgical procedures. News release. Medtronic. December 3, 2025. Accessed December 3, 2025. https://news.medtronic.com/2025-12-03-Medtronic-announces-FDA-clearance-of-Hugo-TM-robotic-assisted-surgery-system-for-urologic-surgical-procedures

2. Abern M, Wiklund P, Goh AC, et al. A prospective, multi-center study assessing effectiveness, safety, and performance of the HUGO robotic-assisted surgery system in the US urologic population: Primary results from the Expand URO IDE study. J Urol. 2025;213(5S2):e4. doi:10.1097/01.JU.0001111604.90306.91.07