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Robot model

Hugo RAS

surgicalcommercialby Medtronic

Medtronic (NYSE: MDT; founded 1949 in Minneapolis, with legal headquarters in Dublin) makes the Hugo robotic-assisted surgery system, the late-market…

Track Hugo RAS
Manufacturer
Medtronic
Form factor
surgical
Maturity
commercial
Lifecycle
active
Deployments
6
Website
news.medtronic.com ↗

The verified answer

As of Sep 2026, DEPLOY verifies Hugo RAS, a surgical by Medtronic (commercial): 6 verified deployments on record. 4 sources back the record.

Regulatory status1 FDA De Novo authorization1 FDA 510(k) clearance

Hugo RAS holds 1 FDA De Novo authorization and 1 FDA 510(k) clearance, per the DEPLOY registry.

See all 2 filings

Overview

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.

Verified vs. claimed

Maturity stage
commercial(Commercially deployed with revenue-generating operations.)
Sources on file
View all sources →

Key facts

FDA 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.

VVC 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.

Specs

Notes

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.

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

Data & sources

Press releases

2

News coverage

1

Web sources

1

4 sources backing this record.View all →

Availability and pricing

Availability
Not sold (internal use)
Price
Not publicly disclosed
Units in field
Not disclosed
Sales model
Not disclosed
Lead time
Not disclosed

Pricing

No verified price is on record for Hugo RAS. Physical-AI systems are often sold through enterprise contracts or operated as a service rather than at a public list price.

How DEPLOY tracks pricing

Deployments (6)

Free to use on your site, with a link back to DEPLOY.

Hugo RAS on the deployment map

View the global map

Where Hugo RAS is verified operating. Explore the deployment map by place and type.

Free to use on your site, with a link back to DEPLOY.

Recent activity

Every change to this record is dated, sourced, and independently verified where marked.

Full change history →

Deployment-verified media (3)

PRIMARY SOURCE
Courtesy of Medtronic

Medtronic's product animation of its Hugo RAS system, showing the modular arm-carts and open console. The animation depicts the system, not an autonomous capability; the arms are surgeon-driven.

From deployment: Dublin, Ireland

PRIMARY SOURCE
Courtesy of Medtronic

Medtronic's footage of a first patient procedure on its Hugo RAS robotic-assisted surgery system. The surgeon teleoperates from a master console; the system is never autonomous.

From deployment: Dublin, Ireland

PRIMARY SOURCE
Courtesy of Medtronic

Medtronic's introduction of its Hugo RAS robotic-assisted surgery system. Hugo is teleoperated by a surgeon from a console; its US FDA clearance covers urologic procedures.

From deployment: Dublin, Ireland

Supply chain (1)

Sensors

Suppliers appear here when verified with at least two strong sources (maker-official / IR / regulatory / standards-body / verified tier-2). Sources are append-only; corrections add new sources rather than rewrite history.

Regulatory filings (2)

Safety record

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

serious
2
moderate
3
minor
2
regulatory action
3
malfunction
3
injury
1

Most recent: Jul 2026

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Incidents affecting Hugo RAS (7)

Includes incidents linked directly to this model or to deployments of it. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Sources (4)

  1. https://news.medtronic.com/2025-12-03-Medtronic-announces-FDA-clearance-of-Hugo-TM-robotic-assisted-surgery-system-for-urologic-surgical-procedures
  2. https://www.urologytimes.com/view/hugo-robot-assisted-surgery-system-launches-on-us-market
  3. https://news.medtronic.com/2026-06-03-Medtronic-submits-510-k-filings-to-expand-Hugo-TM-robotic-assisted-surgery-system-into-general-and-gynecologic-specialties-in-the-United-States
  4. https://www.medtechdive.com/news/medtronic-seeks-clearance-for-hugo-surgical-robot-in-more-indications/821969/

Compare Hugo RAS

Common questions

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.
How much does Hugo RAS cost?
Hugo RAS's price is not publicly disclosed. DEPLOY has no verified price on record for Hugo RAS from Medtronic. Physical-AI systems like this are often sold through enterprise contracts or operated as a service rather than at a public list price; check the manufacturer for the latest.
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 7% 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.
PMC: Hugo RAS vs da Vinci Xi comparative study ScienceDirect: Hugo RAS vs da Vinci outcomes
Methodology: Verified · 4 sources (2 primary) · last reviewed 2026-07-12

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-12

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: surgical

Sources by quality tier

2
primary-company-ir
Company IR disclosure
1
unclassified
Unclassified source
1
secondary-trade-publication
Trade publication

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Hugo RAS.

Recent coverage

Hugo RAS in third-party press

Medtronic to unveil Touch Surgery Aide compute platform at SRS 2026

Jul 21, 2026

Pacemaker manufacturer Medtronic warns patients cybercrooks may have swiped health data

Jul 2, 2026

Medtronic's Hugo surgical robot earns FDA clearance

Jul 1, 2026