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Hugo RAS is Medtronic's modular robotic-assisted surgery system and the first serious multiport challenger to reach the US soft-tissue market, cleared by the FDA for urologic procedures in December 2025 after nearly five years of commercial use across 35+ countries. Its open console and up-to-four independent arm carts contrast with da Vinci's single-boom design, and Medtronic filed in June 2026 to expand US indications into general surgery and gynecology.
- FDA 510(k) clearance for urologic procedures granted December 3, 2025 — the first new multiport soft-tissue surgical robot cleared in the US in over two decades [source]
- First US commercial Hugo case, a robot-assisted prostatectomy, performed at Cleveland Clinic [source]
- June 2026 510(k) filings seek expansion into hernia repair and gynecologic surgery; Embrace gynecology IDE study enrollment completed [source]
Specifications
| Specification | Value | Confidence | Source |
|---|---|---|---|
| Arms | Up to 4 modular arm carts (1-, 3- and 4-arm configurations) | verified | medtronic.com (2026-09-01) |
| Console | Open console with 3D HD display for situational awareness | verified | medtronic.com (2026-09-01) |
| Arm articulation | 6 joints per independent arm, with vertical adjustment on the cart column | reported | frontiersin.org (2026-09-01) |
| Modularity | Independent arm carts movable between operating rooms; use only the carts a procedure needs | reported | frontiersin.org (2026-09-01) |
| Countries in use | 35+ (five continents) countries | verified | news.medtronic.com (2026-09-01) |
| Procedures performed | Tens of thousands globally | verified | news.medtronic.com (2026-09-01) |
Every spec is cited to its source with a retrieval date. verified = manufacturer-published · reported = reputable press/analyst. Verify with the manufacturer before purchase decisions.
Change timeline
- announcement Medtronic submits 510(k) filings to expand Hugo into general and gynecologic surgery in the US [source]
- milestone FDA grants 510(k) clearance for urologic procedures; US launch begins [source]
- milestone Hugo RAS receives European CE mark [source]
Our take
Hugo's pitch is flexibility and economics: modular carts move between ORs, hospitals deploy only the arms they need, and Medtronic can bundle it with its huge surgical-instruments business. Its US indication is still urology-only, so broad head-to-head competition with da Vinci awaits the pending general surgery and gynecology clearances. International experience since 2021 means it arrives in the US as a proven rather than experimental platform.
Best suited for
- Robot-assisted radical prostatectomy
- Nephrectomy and cystectomy
- Hernia repair and gynecologic procedures internationally, pending US clearance
Hugo RAS: common questions
Is the Medtronic Hugo FDA approved?
Yes. The FDA granted 510(k) clearance on December 3, 2025 for urologic procedures including prostatectomy, nephrectomy and cystectomy. Filings to expand into general surgery and gynecology were submitted in June 2026.
How much does the Hugo RAS system cost?
Medtronic has not published pricing. Its modular design lets hospitals configure from one to four arm carts, which affects cost.
How is Hugo different from da Vinci?
Hugo uses separate modular arm carts and an open console rather than a single boom and closed console. Modules can be shared between operating rooms; da Vinci offers a larger installed base and broader US indications.
Where is Hugo already in use?
Per Medtronic, Hugo has nearly five years of commercial experience in more than 35 countries across five continents, with tens of thousands of procedures performed. Its US rollout began in early 2026 at centers including Cleveland Clinic.
Sources
- Medtronic — medtronic.com, retrieved 2026-09-01
- Medtronic Newsroom — news.medtronic.com, retrieved 2026-09-01
- Urology Times — urologytimes.com, retrieved 2026-09-01
- Frontiers in Oncology — frontiersin.org, retrieved 2026-09-01
- Xtalks — xtalks.com, retrieved 2026-09-01
- PR Newswire (Medtronic) — prnewswire.com, retrieved 2026-09-01
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