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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


Machine-readable surfaces

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
Trust tier
Catalog entry · 6 sources · not yet field-verified
Last updated
2026-06-07
Model
Hugo RAS
Company
Medtronic
Location
European Union
Status
active
First seen
2021-10-01
ID
8e464586-88b6-41b9-939a-ef3708d8e617

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 2026-06-07

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-06-07

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.
Is the Hugo RAS deployment at European Union still active?
As of the most recent verification on the DEPLOY registry, this deployment is currently operating.
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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