{"id":"f6916652-6ad6-4f34-b3cd-d8b58f40356a","slug":"regulatory-action-2026-03-26-quantum-surgical","kind":"regulatory_action","headline":"Quantum Surgical receives FDA 510(k) clearance for Epione robot for all abdominal cancers","summary":"Quantum Surgical received FDA 510(k) clearance for its Epione robotic-assisted platform for all abdominal cancer tumor ablation treatments, expanding the indication from initial clearance to cover all abdominal cancers.","occurredAt":"2026-03-26T12:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"cb6a0ecc-6b4d-486d-9356-ea9c928ba0ed","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":"2026-07-08T14:54:36.563Z","updatedAt":"2026-07-08T14:54:36.563Z","model":null,"deployment":null,"company":{"id":"cb6a0ecc-6b4d-486d-9356-ea9c928ba0ed","name":"Quantum Surgical","slug":"quantum-surgical","description":"French medical robotics company developing the [Epione](/models/epione) robotic platform for CT-guided percutaneous tumor ablation, enabling minimally invasive treatment of abdominal, lung, and bone cancers. Founded in 2017 by a team of former [Medtech SA](/companies/medtech-sa) engineers led by Bertin Nahum, the company is headquartered in Montpellier with a US subsidiary in Miami. 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(since Feb 2026)"},{"label":"Patients treated","value":"1400+ (as of 2026)"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"createdAt":"2026-07-06T14:11:34.262Z","updatedAt":"2026-07-09T03:03:50.048Z"},"derived":{"status":"active"},"sources":[{"id":"68a445ef-fa01-42bc-96e6-9f3fa7dff64b","incidentId":"f6916652-6ad6-4f34-b3cd-d8b58f40356a","url":"https://www.quantumsurgical.com/news/fda-clears-quantum-surgicals-epione-robot-for-all-abdominal-cancers","label":null,"publishedAt":null,"notes":null,"title":"FDA clears Quantum Surgical Epione robot for all abdominal cancers","sourceName":"Quantum Surgical","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-08T14:54:36.948Z","updatedAt":"2026-07-08T14:54:36.948Z"}],"responses":[],"statusEvents":[{"id":"1127dbfa-96f5-468f-86ad-086ca3e0ea8d","incidentId":"f6916652-6ad6-4f34-b3cd-d8b58f40356a","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-08T14:54:37.327Z","createdAt":"2026-07-08T14:54:37.328Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/regulatory-action-2026-03-26-quantum-surgical","url":"https://registry.deploy.report/incidents/regulatory-action-2026-03-26-quantum-surgical","headline":"Quantum Surgical receives FDA 510(k) clearance for Epione robot for all abdominal cancers","description":"Quantum Surgical received FDA 510(k) clearance for its Epione robotic-assisted platform for all abdominal cancer tumor ablation treatments, expanding the indication from initial clearance to cover all abdominal cancers.","identifier":"f6916652-6ad6-4f34-b3cd-d8b58f40356a","datePublished":"2026-03-26T12:00:00.000Z","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":[]}}}