Medtronic Hugo RAS System Gains U.S. FDA Clearance

Medtronic has successfully secured initial stateside clearance from the U.S. Food and Drug Administration (FDA) for its Hugo robotic-assisted surgery (RAS) platform, setting the stage for increased competition in the lucrative U.S. robotic surgery market. The clearance, announced December 3, 2025, specifically covers soft-tissue, minimally invasive multiport procedures for urologic surgeries.

This initial green light includes complex procedures such as the removal of the prostate, kidneys, and bladder (prostatectomy, nephrectomy, and cystectomy). Medtronic estimates these procedures account for approximately 230,000 surgeries performed annually in the U.S.. The company views this milestone as a means to expand robotic programs in hospitals and increase patient access to minimally invasive care across the country.

The introduction of Hugo addresses the challenge of capacity and access in the U.S., which leads the world in robotic surgery adoption. Rajit Kamal, Medtronic’s vice president of robotic surgical technologies, stated that the clearance provides choice for hospitals looking to expand their robotic capabilities.

The Hugo system is differentiated by its modular design, featuring multiple robotic arms placed on individual wheeled carts, making the system portable and deployable across any healthcare setting. Furthermore, the system integrates seamlessly with the Touch Surgery digital ecosystem, which supports pre-operative planning, remote tele-proctoring, video education programs, and artificial intelligence-powered insights for clinicians.

Medtronic intends to launch the Hugo RAS system purposefully, building strong foundations with leading hospitals through a commitment to differentiated partnership and world-class training. The company also plans to expand the robot’s scope in the U.S. beyond urology, with indications for general and gynecologic procedures expected to follow. Already active overseas, Hugo has logged tens of thousands of procedures across more than 30 countries and five continents since its 2021 debut.

Hugo enters a competitive arena, vying for market share with major systems like Intuitive's da Vinci 5, as well as newer FDA-cleared international systems such as CMR Surgical’s Versius and Distalmotion’s Dexter. The addition of the Hugo RAS system, coupled with Medtronic's existing surgical offerings, is expected to create a connected and integrated operating room for the future.

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🔖 Sources

Medtronic announces FDA clearance of Hugo™ robotic-assisted surgery system for urologic surgical procedures

Medtronic's Hugo surgical robot secures US clearance

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Keywords: Medtronic Hugo RAS system FDA clearance

 Medtronic Hugo RAS system FDA clearance

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