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Deployment

Hugo RAS at European Union

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.

Hugo RAS by Medtronic · Catalog entry · 6 sources · not yet field-verified · Surgical robots

Track Hugo RAS at European Union

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Machine-readable surfaces

Footage

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.

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.

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.

Medtronic received CE Mark approval for the Hugo robotic-assisted surgery system in October 2021, enabling its commercial availability in the European Union. The first procedure in Europe using the Hugo system was announced on February 2, 2022.

Key facts

First CE mark
October 2021 (EU launch before US)
First commercial sites
Europe-first launch: hospitals in France, Germany, Italy
FDA status
Investigational Device Exemption studies; not yet FDA-cleared for US commercial sale as of 2026

Safety record

No incidents on record for Hugo RAS at European Union.

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

Trust tier
Catalog entry · 6 sources · not yet field-verifiedhow tiers work →
Last updated
2026-06-28
Model
Hugo RAS
Company
Medtronic
Location
European Union
Status
operational
First seen
2021-10-01
ID
8e464586-88b6-41b9-939a-ef3708d8e617

Timeline

  1. Oct 2021
    First recorded
    Hugo RAS first documented operating at European Union.
  2. Oct 2021
    created
  3. Jun 2026
    Current status: operational, reviewed
    Latest recorded state. New status transitions append here as the deployment-status recorder produces them.

On the deployment map

Hugo RAS operates in European Union. Explore the full verified map:

Sources (6)

  1. https://news.medtronic.com/news/2021/10/05/medtronic-announces-ce-mark-for-hugo-robotic-assisted-surgery-system
  2. https://www.medtronic.com/us-en/healthcare-professionals/products/robotic-assisted-surgery/hugo-ras-system.html
  3. https://news.medtronic.com/2022-02-02-Medtronic-announces-first-procedure-in-Europe-with-Hugo-TM-robotic-assisted-surgery-system
  4. https://news.medtronic.com/2021-10-11-Medtronic-Hugo-TM-Robotic-Assisted-Surgery-System-Receives-European-CE-Mark-Approval
  5. https://news.medtronic.com/2021-06-22-First-Procedure-in-the-World-with-Medtronic-Hugo-TM-Robotic-Assisted-Surgery-System-Performed-at-Clinica-Santa-Maria-in-Chile
  6. https://www.therobotreport.com/medtronic-hugo-surgical-robot-first-clinical-procedure/
Methodology: Verified · 6 sources (no primary) · last reviewed 2026-06-28

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-06-28

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: surgical

Sources by quality tier

5
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 at European Union.

Common questions

What is the Hugo RAS deployment at European Union?
Hugo RAS, built by Medtronic, is recorded as a deployment at European Union on the DEPLOY registry. Medtronic operates the deployment directly.
Who operates Hugo RAS at European Union?
Medtronic, the manufacturer of Hugo RAS, operates this deployment directly. This is a maker-deploys-its-own-product arrangement rather than a customer pilot.
When did the Hugo RAS deployment at European Union go live?
The deployment is recorded as starting October 1, 2021 on the DEPLOY registry. Earlier activity may exist but is not yet sourced.
Have there been incidents at the Hugo RAS deployment at European Union?
No active incidents affecting this deployment are recorded on the DEPLOY registry. Absence of recorded incidents is not a guarantee no incident occurred; DEPLOY records only sourced incidents and suppresses retracted ones.

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