{"id":"38bee79c-d799-41b7-b511-c790e17f0eef","slug":"regulatory-action-2026-06-15-distalmotion","kind":"regulatory_action","headline":"Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications","summary":"Distalmotion secured FDA 510(k) clearance for Dexter robotic surgery system for additional gynecology indications: sacrocolpopexy, sacrocervicopexy, sacrohysteropexy. Previously cleared for gallbladder, hysterectomy, hernia repair.","occurredAt":"2026-06-15T12:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"bba39508-3e95-4e2f-b736-9bd5ff7e567b","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,"createdAt":"2026-07-03T05:05:16.027Z","updatedAt":"2026-07-03T05:05:16.027Z","model":null,"deployment":null,"company":{"id":"bba39508-3e95-4e2f-b736-9bd5ff7e567b","name":"Distalmotion","slug":"distalmotion","description":"Distalmotion is a Swiss surgical robotics company based in Lausanne, developing the Dexter robotic surgery system for minimally invasive abdominal surgery, combining remote-center motion with a compact, ergonomic surgical platform.","status":"private (raised $150M Nov 2025)","founded":2012,"hq":"Lausanne, Switzerland","fundingTotal":null,"type":"both","reviewStatus":"reviewed","sources":[{"url":"https://www.biospace.com/distalmotion-dexter-fda-de-novo","title":"FDA grants De Novo marketing authorization for the Distalmotion Dexter robot (Oct 2024)","sourceName":"BioSpace"},{"url":"https://www.bioworld.com/articles/distalmotion-ce-mark-dexter","title":"Distalmotion wins CE mark for Dexter surgical robot (Dec 2020)","sourceName":"BioWorld"},{"url":"https://www.globenewswire.com/news-release/2025/11/18/distalmotion-150-million","title":"Distalmotion raises $150M to accelerate US expansion (Nov 18 2025)","sourceName":"Distalmotion (GlobeNewswire)"},{"url":"https://www.massdevice.com/distalmotion-dexter-fda-clearance/","title":"Distalmotion Dexter FDA clearances; ASC cost-efficiency positioning","sourceName":"MassDevice"}],"keyFacts":[{"label":"Product","value":"Dexter hybrid laparoscopic surgical robot (robotic <-> manual mid-procedure); ASC cost-efficiency."},{"label":"Gating events","value":"CE Dec 2020; FDA De Novo Oct 2024 (inguinal hernia) + cholecystectomy + hysterectomy."},{"label":"Origin","value":"EPFL spinout"},{"label":"Patients treated","value":"~3,000 patients"}],"aliases":["Distalmotion SA","Dexter"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-06-03T20:13:10.291Z","updatedAt":"2026-07-03T17:30:14.148Z"},"derived":{"status":"active"},"sources":[{"id":"34716658-5928-4337-8d97-9a6a687f0bfd","incidentId":"38bee79c-d799-41b7-b511-c790e17f0eef","url":"https://www.medtechdive.com/news/distalmotion-targets-asc-robotic-gynecology-programs-with-fda-filing/816296/","label":null,"publishedAt":null,"notes":null,"title":"Distalmotion targets ASC robotic gynecology programs with FDA filing","sourceName":"MedTech Dive","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-03T05:05:16.179Z","updatedAt":"2026-07-03T05:05:16.179Z"}],"responses":[],"statusEvents":[{"id":"39ce831e-a275-406c-a3cf-17c325f04cf9","incidentId":"38bee79c-d799-41b7-b511-c790e17f0eef","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-03T05:05:16.333Z","createdAt":"2026-07-03T05:05:16.334Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/regulatory-action-2026-06-15-distalmotion","url":"https://registry.deploy.report/incidents/regulatory-action-2026-06-15-distalmotion","headline":"Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications","description":"Distalmotion secured FDA 510(k) clearance for Dexter robotic surgery system for additional gynecology indications: sacrocolpopexy, sacrocervicopexy, sacrohysteropexy. Previously cleared for gallbladder, hysterectomy, hernia repair.","identifier":"38bee79c-d799-41b7-b511-c790e17f0eef","datePublished":"2026-06-15T12:00:00.000Z","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":["secondary-trade-publication"]}}}