{"id":"f8736f5b-ee8d-4949-9b17-902614072b1d","slug":"regulatory-action-2025-03-26-quantum-surgical","kind":"regulatory_action","headline":"FDA clears Quantum Surgical Epione robot for abdominal tumor ablation","summary":"Quantum Surgical's Epione robotic platform received FDA clearance for the abdominal ablation indication. Epione assists physicians in performing percutaneous tumor ablations. The device is also CE marked for abdomen, chest, and musculoskeletal indications. Over 1,400 patients have been treated in Europe and the U.S.","occurredAt":"2025-03-26T12:00:00.000Z","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,"createdAt":"2026-07-06T14:11:52.320Z","updatedAt":"2026-07-06T14:11:52.320Z","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. Now part of Precision IO Group after acquiring NeuWave Medical in February 2026, with over 1,400 patients treated across Europe and the United States.","status":null,"founded":2017,"hq":"Montpellier, France","fundingTotal":"86923000","type":"hardware","reviewStatus":"reviewed","sources":[{"url":"https://www.quantumsurgical.com/news/fda-clears-quantum-surgicals-epione-robot-for-all-abdominal-cancers","title":"FDA clears Quantum Surgical's Epione robot for all abdominal cancers","sourceName":"Quantum Surgical"}],"keyFacts":[{"label":"FDA cleared","value":"abdominal ablation indication"},{"label":"CE marked","value":"abdomen, chest, musculoskeletal"},{"label":"Acquired NeuWave Medical","value":"Feb 2026"},{"label":"CEO","value":"Bertin Nahum (President & Co-founder)"},{"label":"Group CEO","value":"Kurt Azarbarzin (Precision IO Group, appointed Feb 2026)"},{"label":"Co-founders","value":"Bertin Nahum, Fernand Badano, Lucien Blondel, Sophie Roca"},{"label":"Total funding","value":"approx 90M USD (50M EUR equity + 30M EUR EIB loan)"},{"label":"FDA clearance","value":"510(k) K223758 for abdominal tumor ablation"},{"label":"CE mark","value":"abdomen, lung, and musculoskeletal indications"},{"label":"Parent company","value":"Precision IO Group Inc. (since Feb 2026)"},{"label":"Patients treated","value":"1400+ (as of 2026)"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-07-06T14:11:34.262Z","updatedAt":"2026-07-06T15:24:10.692Z"},"derived":{"status":"active"},"sources":[{"id":"fe056bab-d574-449d-b1d3-b7b7f0a0b067","incidentId":"f8736f5b-ee8d-4949-9b17-902614072b1d","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's Epione robot for all abdominal cancers","sourceName":"Quantum Surgical","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-06T14:11:52.702Z","updatedAt":"2026-07-06T14:11:52.702Z"}],"responses":[],"statusEvents":[{"id":"6f92c5cd-6a1b-478b-af39-3ed30f86d89b","incidentId":"f8736f5b-ee8d-4949-9b17-902614072b1d","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-06T14:11:53.086Z","createdAt":"2026-07-06T14:11:53.087Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/regulatory-action-2025-03-26-quantum-surgical","url":"https://registry.deploy.report/incidents/regulatory-action-2025-03-26-quantum-surgical","headline":"FDA clears Quantum Surgical Epione robot for abdominal tumor ablation","description":"Quantum Surgical's Epione robotic platform received FDA clearance for the abdominal ablation indication. Epione assists physicians in performing percutaneous tumor ablations. The device is also CE marked for abdomen, chest, and musculoskeletal indications. Over 1,400 patients have been treated in Europe and the U.S.","identifier":"f8736f5b-ee8d-4949-9b17-902614072b1d","datePublished":"2025-03-26T12:00:00.000Z","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":[]}}}