Hugo RAS

[commercial]

surgical · food-service · 6 deployments in catalog

Field Advisory

Verified: Medtronic (NYSE: MDT; founded 1949, Minneapolis; legal HQ Dublin) makes Hugo RAS, the late-market big-medtech challenger to da Vinci. CE mark Oct 11 2021. US FDA clearance Dec 3 2025 for urologic procedures only, backed by the Expand URO IDE trial (137 patients; met primary safety + efficacy endpoints; AUA 2025). The key audit finding: Hugo IS now FDA-cleared in the US, but only for urology., Installed base: cap-flag: Medtronic states Hugo has been used ex-US in 'tens of thousands of procedures in 30+ countries across 5 continents' but discloses NO specific system installed-base count. Accept lower specificity; do not invent a number., AI-substance: teleop baseline: Master-slave teleoperated. The integrated Touch Surgery digital/video ecosystem is analytics/recording, not autonomy or shipped intraoperative AI guidance. No verified shipped autonomous or computer-vision-guidance feature., Claimed but NOT verified: Specific US installed-base unit count (none disclosed); 'tens of thousands of procedures' ex-US is company-stated, not audited; timeline for general-surgery/gynecology US clearances is forward-looking.

Manufacturer

Medtronic

Form Factor

surgical

Lifecycle

commercial

Operational Reality

Audited

Deployments

6

Target Price

Not publicly disclosed

  • SURGICAL
  • COMMERCIAL

Description

Medtronic (NYSE: MDT; founded 1949 in Minneapolis, with legal headquarters in Dublin) makes the Hugo robotic-assisted surgery system, the late-market big-medtech challenger to Intuitive's da Vinci. Hugo is a modular multi-port teleoperated platform that received its European CE mark for urologic and gynecologic procedures on October 11, 2021, and, in the key regulatory milestone, US FDA clearance on December 3, 2025 for urologic procedures only, including prostatectomy, nephrectomy, and cystectomy, backed by the Expand URO investigational-device-exemption trial of 137 patients that met its primary safety and efficacy endpoints and was presented at AUA 2025. General-surgery and gynecologic US indications are planned submissions but are not yet cleared. The registry records Hugo at commercial maturity: it has been CE-marked and commercially used outside the US across more than 30 countries since 2021 and is now US-cleared for urology and entering US rollout. Medtronic discloses no specific system installed-base count, citing only tens of thousands of procedures across 30-plus countries, so the unit count is left as an honest absence rather than invented. On AI substance, Hugo is a master-slave teleoperated system whose Touch Surgery digital and video ecosystem is analytics and recording rather than autonomy, with no verified shipped intraoperative AI guidance.

Key facts & specs

15 entries
website
https://news.medtronic.com/2025-12-03-Medtronic-announces-FDA-clearance-of-Hugo-TM-robotic-assisted-surgery-system-for-urologic-surgical-procedures
maturity
commercial
lifecycle
active
manufacturer
Medtronic
deployments count
6
Maturity stage
commercial
Products
Hugo RAS (robotic-assisted surgery): modular multi-port teleoperated system; CE-marked (urology + gynecology) Oct 11 2021; US FDA-cleared for UROLOGY ONLY Dec 3 2025 (prostatectomy/nephrectomy/cystectomy). General-surgery + gynecology US indications: submissions planned, NOT yet cleared.
Form Factor
surgical (modular multi-port teleoperated robotic-assisted surgery system)
Fda clearance
December 3, 2025
Clearance body
FDA
Procedure types
urologic procedures only, including prostatectomy, nephrectomy, and cystectomy
F D A clearance (verified)
510(k) cleared for urologic surgical procedures, Dec 3, 2025. Commercially available in the US for urology.
Expansion filing (pending)
510(k) filings submitted Jun 3, 2026 for general and gynecologic specialties. FDA review pending -- clearance not yet granted.
V V C flag
Urology clearance is verified and commercial. General/gynecologic expansion is a filing, not a clearance -- do not record as cleared until FDA acts.
Subprocessors
Modular console-based robotic-assisted surgery system; multi-arm configuration.

Availability and pricing

price
Not publicly disclosed
lead time
Not disclosed
sales model
Not disclosed
availability
Not sold (internal use)
units in field
Not disclosed
pricing Model
Not disclosed

Safety record

Safety Status
7 incident(s) logged

7 incidents on record (2 serious, 3 moderate, 2 minor). Most recent: Jul 2026.

Risk Metrics
Incidents: 7
Recalls: 0
Latest: Jul 2026
minor: 2
serious: 2
moderate: 3

Supply chain

1 entry
  • Karl Storz SE & Co. KG 3D vision system / TIPCAM 1 S 3D video endoscope (IMAGE1 S platform)

    Karl Storz SE & Co. KG 3D vision system / TIPCAM 1 S 3D video endoscope (IMAGE1 S platform)

FAQ

13 entries
What is Hugo RAS?

Medtronic (NYSE: MDT; founded 1949 in Minneapolis, with legal headquarters in Dublin) makes the Hugo robotic-assisted surgery system, the late-market big-medtech challenger to Intuitive's da Vinci. Hugo is a modular multi-port teleoperated platform that received its European CE mark for urologic and gynecologic procedures on October 11, 2021, and, in the key regulatory milestone, US FDA clearance on December 3, 2025 for urologic procedures only, including prostatectomy, nephrectomy, and cystectomy, backed by the Expand URO investigational-device-exemption trial of 137 patients that met its primary safety and efficacy endpoints and was presented at AUA 2025. General-surgery and gynecologic US indications are planned submissions but are not yet cleared. The registry records Hugo at commercial maturity: it has been CE-marked and commercially used outside the US across more than 30 countries since 2021 and is now US-cleared for urology and entering US rollout. Medtronic discloses no specific system installed-base count, citing only tens of thousands of procedures across 30-plus countries, so the unit count is left as an honest absence rather than invented. On AI substance, Hugo is a master-slave teleoperated system whose Touch Surgery digital and video ecosystem is analytics and recording rather than autonomy, with no verified shipped intraoperative AI guidance.

Is Hugo RAS actually deployed in the real world?

Yes. Hugo RAS is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.

Is Hugo RAS autonomous or teleoperated?

Not verified as fully autonomous. Hugo RAS's capabilities on the DEPLOY registry are recorded as teleoperated-assisted, demonstrated-only, or vendor claims (Assists surgery), not independently confirmed to run without a human in the loop.

Who makes Hugo RAS?

Hugo RAS is made by Medtronic, based in Dublin, Ireland, founded in 1949.

Where is Hugo RAS deployed?

6 verified deployments of Hugo RAS are on the DEPLOY registry, including at United States (multiple hotel chains), Cleveland, United States.

Can you buy Hugo RAS?

Hugo RAS is in commercial deployment and is sold to operators; contact the manufacturer to buy, and see the pricing section for any recorded price.

Is Hugo RAS FDA cleared?

Hugo RAS has 2 regulatory records on the DEPLOY registry: FDA De Novo authorization, cleared; FDA 510(k) clearance (K250725), granted. See the Regulatory filings section for each agency source.

What are alternatives to Hugo RAS?

On the DEPLOY registry, comparable surgical robots to Hugo RAS include da Vinci (and Ion), Edge Multi-Port Surgical Robot, Edison Histotripsy System, Stryker Mako SmartRobotics.

How does Hugo RAS compare to da Vinci (and Ion)?

Hugo RAS and da Vinci (and Ion) (Intuitive Surgical · 15 deployments) are both surgical robots on the DEPLOY registry. Hugo RAS has 6 verified deployments on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.

Is Hugo RAS a top surgical?

On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, Hugo RAS ranks in roughly the top 5% of surgical models tracked by the registry.

What is Hugo RAS's maturity stage?

Hugo RAS is at the commercial stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Commercial stage means production-grade deployments are operating at named customer sites.

Is Hugo RAS safe?

Hugo RAS has 7 active incidents on record in the DEPLOY registry. 7 incidents on record (2 serious, 3 moderate, 2 minor). Most recent: Jul 2026. Retracted incidents are excluded from this count.

How does Medtronic Hugo RAS compare to da Vinci?

Peer-reviewed studies show no significant differences in hospital stay length, blood loss, or complication rates between Hugo RAS and da Vinci Xi. Da Vinci has shorter docking and console times. Hugo RAS is Medtronic's challenger to Intuitive's da Vinci dominance, with a modular design and open architecture. Da Vinci remains the market leader with a much larger installed base.

Deployments

6 entries

Incidents affecting Hugo RAS

7 entries

Sectors & applications

1 entry