{"id":"6bda2e20-1939-473e-874a-709523d10d5f","slug":"regulatory-action-2025-12-17-cmr-surgical","kind":"regulatory_action","headline":"FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))","summary":"CMR Surgical received FDA 510(k) clearance for its second-generation Versius Plus surgical robotic platform, covering cholecystectomy (gallbladder removal) procedures. The clearance follows FDA's de novo authorization of the first-generation Versius in October 2024. CMR plans U.S. commercialization in 2026.","occurredAt":"2025-12-17T12:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"6bbb447e-0278-4ae1-822d-8b546420511e","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"minor","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"other","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"createdAt":"2026-07-06T14:10:48.666Z","updatedAt":"2026-07-06T14:10:48.666Z","model":null,"deployment":null,"company":{"id":"6bbb447e-0278-4ae1-822d-8b546420511e","name":"CMR Surgical","slug":"cmr-surgical","description":"UK surgical-robotics company (Cambridge; founded 2014) making the Versius modular multi-arm teleoperated surgical robot; FDA De Novo 2024 + Versius Plus 510(k) 2025; >40k procedures ex-US.","status":"private (recapitalized $200M+ Apr 2025; current valuation unconfirmed)","founded":2014,"hq":"Cambridge, United Kingdom","fundingTotal":null,"type":"both","reviewStatus":"reviewed","sources":[{"url":"https://www.globenewswire.com/news-release/2024/10/15/cmr-surgical-versius-fda-de-novo","title":"CMR Surgical receives US FDA De Novo for Versius (cholecystectomy; Oct 2024)","sourceName":"CMR Surgical (GlobeNewswire)"},{"url":"https://www.therobotreport.com/cmr-surgical-receives-fda-clearance-for-versius-plus-surgical-robot/","title":"CMR Surgical FDA 510(k) for Versius Plus (Dec 18 2025; US launch 2026)","sourceName":"The Robot Report"},{"url":"https://www.massdevice.com/cmr-surgical-200-million-funding/","title":"CMR Surgical raises $200M+ to fund US/Asia commercialization (Apr 2025)","sourceName":"MassDevice"},{"url":"https://www.globenewswire.com/news-release/2026/03/17/cmr-surgical-nvidia-igx-thor","title":"CMR Surgical + NVIDIA IGX Thor (evaluating AI for next-gen Versius; R&D-stage)","sourceName":"CMR Surgical (GlobeNewswire)"}],"keyFacts":[{"label":"Product","value":"Versius / Versius Plus modular multi-arm teleoperated surgical robot."},{"label":"Gating events","value":"FDA De Novo Oct 2024; Versius Plus 510(k) Dec 2025; gynecology 510(k) pending."},{"label":"wikidata","value":"https://www.wikidata.org/wiki/Q60775579"},{"label":"wikipedia","value":"https://en.wikipedia.org/wiki/CMR_Surgical"},{"label":"Founded","value":"2014, Cambridge, UK"},{"label":"Key product","value":"Versius surgical robot system"},{"label":"FDA clearance","value":"Versius Plus secured"}],"aliases":["CMR","Cambridge Medical Robotics","Versius"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"createdAt":"2026-06-03T20:12:28.328Z","updatedAt":"2026-07-08T03:25:33.274Z"},"derived":{"status":"active"},"sources":[{"id":"3d8d502e-e386-4e37-8ebb-da6f8fc275fe","incidentId":"6bda2e20-1939-473e-874a-709523d10d5f","url":"https://www.mddionline.com/robotics/fda-clears-new-robotic-platform-for-gallbladder-surgery","label":null,"publishedAt":null,"notes":null,"title":"FDA Clears New Robotic Platform for Gallbladder Surgery","sourceName":"MD+DI","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-06T14:10:49.052Z","updatedAt":"2026-07-06T14:10:49.052Z"}],"responses":[],"statusEvents":[{"id":"ce1e916c-7631-4cfc-aa6a-ccf146f0f1a6","incidentId":"6bda2e20-1939-473e-874a-709523d10d5f","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-06T14:10:49.434Z","createdAt":"2026-07-06T14:10:49.436Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/regulatory-action-2025-12-17-cmr-surgical","url":"https://registry.deploy.report/incidents/regulatory-action-2025-12-17-cmr-surgical","headline":"FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))","description":"CMR Surgical received FDA 510(k) clearance for its second-generation Versius Plus surgical robotic platform, covering cholecystectomy (gallbladder removal) procedures. The clearance follows FDA's de novo authorization of the first-generation Versius in October 2024. CMR plans U.S. commercialization in 2026.","identifier":"6bda2e20-1939-473e-874a-709523d10d5f","datePublished":"2025-12-17T12:00:00.000Z","articleSection":"regulatory action","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":[]}}}