Buying guide
Hugo RAS
By Medtronic · surgical
- Price
- —
- Availability
- Internal use only (not for retail).
- Maturity
- commercial
- Real-world use
- Yes, 4 verified deployments
Medtronic's Hugo RAS is a modular, multi-port teleoperated robotic-assisted-surgery system and the main commercial competitor to Intuitive's da Vinci. It is CE-marked in Europe (urology and gynecology, October 2021) and US FDA-cleared for urology only (December 2025: prostatectomy, nephrectomy, cystectomy); US general-surgery and gynecology indications are planned but not yet cleared. It is teleoperated with no shipped intraoperative AI. Medtronic does not disclose a Hugo installed-base count, so DEPLOY records honest absence rather than an invented number. It is enterprise B2B equipment; there is no consumer price.
Readiness
Hugo RAS is internal use only (not for retail), the 1 capability claim on file is all teleoperated-assisted with claimed, 4 verified deployments are on file, and 7 incidents are on record.
- Availability
- internal-only
Internal use only (not for retail).
- Price honesty
- no-price
No price points on file for Hugo RAS.
- Capability honesty
- teleoperated-assisted
1 reviewed claim: teleoperated-assisted, claimed.
- Real-world use
- commercial
Maturity: commercial. 4 verified deployments in the registry.
- Safety record
- incidents-on-file
7 incidents on record across 4 verified deployments.
What it claims to do
- Assists surgeryteleoperated-assisted· claimedevidence ↗
Price
No reviewed price points on file.
Real-world use
- Cleveland operated by Medtronic2026-02-17
- Dublin, Ireland operated by Medtronic2024-06-01
- United States operated by Medtronic2024-01-01
- European Union operated by Medtronic2021-10-01
Safety record
- Medtronic Hugo surgical robot earns FDA clearance for additional indication2026-07-01
- Medtronic Hugo RAS: failure to calibrate with the application program freezing or failing to launch (FDA MAUDE)2026-05-21
- Medtronic Hugo RAS: unintended collision with the application program freezing or failing to launch (FDA MAUDE)2026-05-14
- Medtronic Hugo RAS: bipolar grasper broke and dropped a resin insulator fragment into a patient (FDA MAUDE)2026-05-11
- Medtronic Hugo robotic surgery system cleared by FDA for urologic procedures2026-02-15
- Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (FDA MAUDE)2026-01-16
- FDA clears Medtronic Hugo robotic-assisted surgery system for urologic procedures2025-12-03
Privacy
No privacy practices disclosed or on file for Hugo RAS.
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.
- formFactor
- 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
What's under the hood
No brain on file for Hugo RAS.
Frequently asked questions
Is the Hugo RAS actually available for purchase?
Not available to consumers. In internal use by Medtronic.Source: Medtronic: FDA clearance of Hugo RAS for urologic procedures (Dec 3 2025)
What does the Hugo RAS cost?
Not announced.
Does the Hugo RAS really assists surgery?
Claimed at teleoperator-assisted autonomy; verification status: claimed.Sources: Hugo RAS System -- Medtronic product page; modular robotic-assisted surgical system for soft-tissue procedures (urology, gynecology, general surgery); CE marked and cleared in multiple markets, Medtronic gets EU clearance for Hugo robotic surgery system -- Reuters, January 2021; CE mark obtained; commercial launch followed in 2022 in Europe and select international markets
Where is the Hugo RAS being used?
Hugo RAS is in use at: Cleveland operated by Medtronic (2026-02-17), Dublin, Ireland operated by Medtronic (2024-06-01), United States operated by Medtronic (2024-01-01), and European Union operated by Medtronic (2021-10-01).Source: Medtronic announces first surgery with Hugo RAS system in the U.S. performed at Cleveland Clinic
Is the Hugo RAS safe?
Incidents on record: 7 (3 regulatory_action, 3 malfunction, 1 injury). See Medtronic Hugo surgical robot earns FDA clearance for additional indication.Source: Medtronic Hugo surgical robot earns FDA clearance for additional indication
How does the Hugo RAS handle privacy?
No privacy practices disclosed or on file for Hugo RAS.
Who makes the Hugo RAS?
Hugo RAS is made by Medtronic, based in Dublin, Ireland.Source: Medtronic: FDA clearance of Hugo RAS for urologic procedures (Dec 3 2025)
Video
PRIMARY SOURCE
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
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
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.
Manufacturer
Medtronic (registry record: /companies/medtronic)
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Sources
- Medtronic: FDA 510(k) clearance of Hugo RAS for urologic surgical procedures (Dec 3, 2025) · https://news.medtronic.com/2025-12-03-Medtronic-announces-FDA-clearance-of-Hugo-TM-robotic-assisted-surgery-system-for-urologic-surgical-procedures
- Urology Times: Hugo RAS launches on US market following FDA clearance · https://www.urologytimes.com/view/hugo-robot-assisted-surgery-system-launches-on-us-market
- Medtronic: 510(k) filings submitted to expand Hugo RAS into general and gynecologic specialties (Jun 3, 2026) · 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
- MedTech Dive: Medtronic seeks FDA clearance for Hugo in general and gynecologic surgery (Jun 2026) · https://www.medtechdive.com/news/medtronic-seeks-clearance-for-hugo-surgical-robot-in-more-indications/821969/
- Medtronic Hugo RAS receives European CE mark (Oct 11 2021) · https://news.medtronic.com/2021-10-11-Medtronic-Hugo-TM-Robotic-Assisted-Surgery-System-Receives-European-CE-Mark-Approval
- FDA grants Hugo RAS clearance for urologic procedures (Expand URO trial) · https://www.urologytimes.com/view/fda-grants-clearance-to-hugo-robotic-assisted-surgery-system-for-urologic-procedures
- Hugo RAS System -- Medtronic product page; modular robotic-assisted surgical system for soft-tissue procedures (urology, gynecology, general surgery); CE marked and cleared in multiple markets · https://www.medtronic.com/en-us/healthcare-professionals/products/surgical/robotic-assisted-surgery/hugo-ras-system.html
- Medtronic gets EU clearance for Hugo robotic surgery system -- Reuters, January 2021; CE mark obtained; commercial launch followed in 2022 in Europe and select international markets · https://www.reuters.com/business/healthcare-pharmaceuticals/medtronic-gets-eu-clearance-hugo-robotic-surgery-system-2021-01-29/ · 2021-01-29
- Medtronic official YouTube (@medtronicsurgical), embedded under standard YouTube embed terms. oEmbed author_url verified 2026-06-04. Maker product video; surgeon-teleoperated/assisted system, not autonomous. · https://www.youtube.com/watch?v=iWVztKhUb8Q · 2026-06-04
- Medtronic announces first surgery with Hugo RAS system in the U.S. performed at Cleveland Clinic · https://news.medtronic.com/2026-02-17-Medtronic-announces-first-surgery-with-Hugo-TM-robotic-assisted-surgery-system-in-the-U-S-performed-at-Cleveland-Clinic
- Cleveland Clinic First Hospital in the U.S. To Perform Robotic-Assisted Prostate Surgery Using Newly FDA-Cleared System · https://newsroom.clevelandclinic.org/2026/02/17/cleveland-clinic-first-hospital-in-the-us-to-perform-robotic-assisted-prostate-surgery-using-newly-fda-cleared-system
- Medtronic · https://www.medtronic.com/
- Medtronic Hugo RAS — US product page · https://www.medtronic.com/us-en/healthcare-professionals/products/surgical/robotic-assisted-surgery/hugo-ras-system.html
- Medtronic Hugo FDA clearance, December 2023 · https://news.medtronic.com/2023-12-12-Medtronic-Receives-FDA-Clearance-for-Hugo-RAS-System
- Medtronic announces CE mark for Hugo RAS · https://news.medtronic.com/news/2021/10/05/medtronic-announces-ce-mark-for-hugo-robotic-assisted-surgery-system
- Hugo RAS system · https://www.medtronic.com/us-en/healthcare-professionals/products/robotic-assisted-surgery/hugo-ras-system.html
- First Europe procedure OLV Hospital Belgium Feb 2022 · https://news.medtronic.com/2022-02-02-Medtronic-announces-first-procedure-in-Europe-with-Hugo-TM-robotic-assisted-surgery-system
- First worldwide procedure Chile Jun 2021 · 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
- Robot Report: Hugo first clinical procedure · https://www.therobotreport.com/medtronic-hugo-surgical-robot-first-clinical-procedure/
Recent coverage
- Medtronic to unveil Touch Surgery Aide compute platform at SRS 2026Ben Smith, Deploy Editor · 2026-07-21
- Pacemaker manufacturer Medtronic warns patients cybercrooks may have swiped health dataThe Register · 2026-07-02
- Medtronic's Hugo surgical robot earns FDA clearanceBen Smith, Deploy Editor · 2026-07-01
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