{"id":"69fbe692-f287-41c9-8174-8df0588e7ea7","slug":"fda-de-novo-jnj-ottava-clearance","kind":"regulatory_action","headline":"FDA clears J&J Ottava surgical robot for US launch following de novo submission","summary":"Johnson & Johnson received FDA clearance for its Ottava surgical robot for US launch, following a de novo submission in January 2026 and successful FORTE clinical study results in bariatric surgery. Ottava incorporates four robotic arms into a standard-size surgical table and targets general surgery procedures in the upper abdomen.","occurredAt":"2026-07-22T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"effe2229-340b-4d42-bbaa-5ceed51ea610","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,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-07-23T14:06:17.141Z","updatedAt":"2026-07-23T14:06:17.141Z","model":null,"deployment":null,"company":{"id":"effe2229-340b-4d42-bbaa-5ceed51ea610","name":"Johnson and Johnson MedTech","slug":"johnson-johnson-medtech","description":"Johnson and Johnson MedTech is the medical devices division of Johnson and Johnson, developing the Ottava robotic surgical system for soft-tissue surgery. Ottava received FDA De Novo authorization in 2026, positioning it as a competitor to Intuitive Surgical's da Vinci. Nearly six years from first unveiling to FDA clearance.","status":"active","founded":1886,"hq":"New Brunswick, NJ, USA","fundingTotal":null,"type":"hardware","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.reuters.com/business/healthcare-pharmaceuticals/johnson-johnsons-robotic-surgery-device-gets-us-fda-marketing-authorization-2026-07-22/","title":"Johnson and Johnson's robotic surgery device gets U.S. FDA marketing authorization","sourceName":"Reuters","publishedAt":"2026-07-22"}],"keyFacts":[{"label":"FDA clearance","value":"De Novo authorization for Ottava, July 22, 2026"},{"label":"Product","value":"Ottava table-integrated robotic surgical system"},{"label":"HQ","value":"New Brunswick, NJ, USA"},{"label":"Parent","value":"Johnson and Johnson (NYSE JNJ)"},{"label":"FDA","value":"De Novo authorization for general surgery procedures"},{"label":"Competitor","value":"Intuitive Surgical da Vinci"},{"label":"Timeline","value":"First unveiled ~2020, IDE approval late 2025, FDA De Novo 2026"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-07-23T13:20:44.413Z","updatedAt":"2026-07-23T13:52:10.495Z"},"derived":{"status":"active"},"sources":[{"id":"b9afaacb-7474-4233-8164-c6503235ab23","incidentId":"69fbe692-f287-41c9-8174-8df0588e7ea7","url":"https://firstwordhealthtech.com/story/7767634","label":"FirstWord HealthTech","publishedAt":"2026-07-22T00:00:00.000Z","notes":null,"title":null,"sourceName":"FirstWord HealthTech","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-23T14:06:17.141Z","updatedAt":"2026-07-23T14:06:17.141Z"}],"responses":[],"statusEvents":[{"id":"cdaaba3e-8f19-487d-b3fe-e50b4fdc7207","incidentId":"69fbe692-f287-41c9-8174-8df0588e7ea7","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-23T14:06:18.252Z","createdAt":"2026-07-23T14:06:18.252Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/fda-de-novo-jnj-ottava-clearance","url":"https://registry.deploy.report/incidents/fda-de-novo-jnj-ottava-clearance","headline":"FDA clears J&J Ottava surgical robot for US launch following de novo submission","description":"Johnson & Johnson received FDA clearance for its Ottava surgical robot for US launch, following a de novo submission in January 2026 and successful FORTE clinical study results in bariatric surgery. Ottava incorporates four robotic arms into a standard-size surgical table and targets general surgery procedures in the upper abdomen.","identifier":"69fbe692-f287-41c9-8174-8df0588e7ea7","datePublished":"2026-07-22T00:00:00.000Z","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":[]}}}