{"id":"3e170eb2-145b-41a2-88d0-8ff93a5f4e78","companyId":"5ed6adff-c714-4880-bb1e-62af35017f4f","modelName":"Hugo RAS","slug":"medtronic-hugo","description":"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.","formFactor":"surgical","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"Verified","value":"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."},{"label":"Installed base: cap-flag","value":"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."},{"label":"AI-substance: teleop baseline","value":"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."},{"label":"Claimed but NOT verified","value":"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)"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://news.medtronic.com/2025-12-03-Medtronic-announces-FDA-clearance-of-Hugo-TM-robotic-assisted-surgery-system-for-urologic-surgical-procedures","title":"Medtronic: FDA clearance of Hugo RAS for urologic procedures (Dec 3 2025)","sourceName":"Medtronic (official)"},{"url":"https://news.medtronic.com/2021-10-11-Medtronic-Hugo-TM-Robotic-Assisted-Surgery-System-Receives-European-CE-Mark-Approval","title":"Medtronic Hugo RAS receives European CE mark (Oct 11 2021)","sourceName":"Medtronic (official)"},{"url":"https://www.urologytimes.com/view/fda-grants-clearance-to-hugo-robotic-assisted-surgery-system-for-urologic-procedures","title":"FDA grants Hugo RAS clearance for urologic procedures (Expand URO trial)","sourceName":"Urology Times"},{"url":"https://www.medtechdive.com/news/medtronic-hugo-surgical-robot-fda-clearance/","title":"Medtronic's Hugo surgical robot earns FDA clearance (urology only)","sourceName":"MedTech Dive"}],"aliases":["Hugo","Hugo RAS","Medtronic Hugo"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"createdAt":"2026-06-03T20:12:09.397Z","updatedAt":"2026-06-03T20:12:09.397Z","jsonLd":{"@context":"https://schema.org","@type":"Product","@id":"https://registry.deploy.report/models/medtronic-hugo","url":"https://registry.deploy.report/models/medtronic-hugo","name":"Hugo RAS","alternateName":["Hugo","Hugo RAS","Medtronic Hugo"],"description":"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.","identifier":"3e170eb2-145b-41a2-88d0-8ff93a5f4e78","category":"surgical","publisher":{"@id":"https://deploy.report/#organization"}}}