Medtronic Gains FDA Clearance for Hugo Robotic System in Urology

Medtronic has received U.S. FDA clearance for its Hugo robotic surgery system in urologic procedures, including prostate removal, positioning the company to compete with Intuitive Surgical in the largest global robotic surgery market. The company plans to expand Hugo’s use to general surgery and gynecology in the U.S. over time.

Hugo, first unveiled in 2019 and CE-marked in Europe in 2021, is now available in over 30 countries and has been used in tens of thousands of procedures. Its modular design, open surgeon console, and digital features differentiate it from competitors. Analysts expect Medtronic may bundle Hugo with other surgical products to increase adoption and drive instrument utilization.

The U.S. rollout is expected to be gradual, with momentum building as Hugo gains additional indications. Medtronic recently reported positive results in hernia repair studies and has begun U.S. gynecologic trials, signaling broader adoption plans.

09-12-2025