DEPLOYDatabase

Robot model

Hugo RAS

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

Manufacturer
Medtronic
Form factor
surgical
Maturity
commercial
Lifecycle
active
Deployments
3

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.)
Verified deployments
3 deployments on file
Sources on file
4 sources, view all

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.

Deployments (3)

  • The Hugo RAS system received FDA clearance in the United States in December 2023, according to a Medtronic announcement.

  • Medtronic Hugo RAS system deployed at hospitals in Europe and emerging markets for minimally invasive surgery.

  • Medtronic received CE Mark approval for the Hugo robotic-assisted surgery system in October 2021, enabling its commercial availability in the European Union.

Hugo RAS on the deployment map

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

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

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

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

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

No incidents on record for Hugo RAS.

Only active incidents are counted. Retracted incidents are excluded from this summary 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.
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