Medtronic Hugo RAS

2025-12-03 · Publisher : Medtronic · Domain : Robotics

The FDA clears Medtronic's Hugo surgical robot for urologic procedures. Already used in more than 30 countries, Hugo becomes the first serious challenger to da Vinci in the US market.

What changes

FDA clearance for prostatectomy, nephrectomy and cystectomy.
Target market: about 230,000 urologic procedures a year in the US.
Already used in tens of thousands of procedures in 30+ countries.
Expansion expected into gynecology and general surgery.

### Background On December 3, 2025, Medtronic announced FDA clearance for its Hugo RAS robotic-assisted surgery system in urologic procedures. Hugo, available for several years in Europe and other regions, can finally be sold in the United States, the world's largest robotic surgery market, dominated by Intuitive's da Vinci. ### Specifications - Cleared indications: urologic procedures, including prostatectomy, nephrectomy and cystectomy. - About 230,000 such urologic procedures each year in the US. - Clearance backed by the Expand URO trial, described by Medtronic as "the largest ever completed" for multi-port robotic urologic surgery in the US, which met its safety and effectiveness endpoints. - System already used in tens of thousands of procedures (urology, gynecology, general surgery) in more than 30 countries on five continents. ### Why it matters For Rajit Kamal, Medtronic VP, the clearance means "there is now choice for hospitals" looking to expand their robotic programs. Medtronic then filed, in June 2026, for expansion into general and gynecologic surgery. ### Key takeaways The first serious crack in Intuitive's near-monopoly in US soft-tissue robotic surgery.

Medtronic Hugo RAS

What changes

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