{"id":"0ef151fe-51d8-4706-af5e-37116f8cfd74","slug":"fda-jj-ottava-denovo-jul2026","kind":"regulatory_action","headline":"FDA grants De Novo marketing authorization to J&J Ottava surgical robot","summary":"On July 22, 2026, the FDA granted De Novo marketing authorization to Johnson and Johnson MedTech for its Ottava robotically-assisted surgical system, clearing the company to enter the US soft-tissue robotic surgery market. Ottava integrates robotic arms into the operating table, reducing footprint by 30-50 percent versus conventional cart-mounted systems. J&J plans a phased commercial launch with clinician training.","occurredAt":"2026-07-22T00:00:00.000Z","reviewStatus":"unreviewed","modelId":"aa3172dd-364a-4296-873b-25ad26747519","deploymentId":null,"companyId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":null,"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":"2026-07-23T13:22:08.470Z","updatedAt":"2026-07-23T13:22:08.470Z","model":{"id":"aa3172dd-364a-4296-873b-25ad26747519","companyId":"effe2229-340b-4d42-bbaa-5ceed51ea610","modelName":"Ottava","slug":"ottava","description":"Table-integrated robotically-assisted surgical system for soft-tissue procedures. Robotic arms are built into the operating table, reducing the system footprint by 30-50 percent compared to conventional boom- or cart-mounted systems. FDA De Novo marketing authorization granted July 22, 2026 for upper-abdominal procedures.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"unreviewed","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"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"Manufacturer","value":"Johnson and Johnson MedTech"},{"label":"Type","value":"Surgical robot"},{"label":"Maturity","value":"Commercially available"}],"createdAt":"2026-07-23T13:20:45.180Z","updatedAt":"2026-07-23T13:20:45.180Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null},"deployment":null,"company":null,"derived":{"status":"active"},"sources":[{"id":"cf686cd8-9bc8-4add-9c49-3b6236c0576e","incidentId":"0ef151fe-51d8-4706-af5e-37116f8cfd74","url":"https://www.reuters.com/business/healthcare-pharmaceuticals/johnson-johnsons-robotic-surgery-device-gets-us-fda-marketing-authorization-2026-07-22/","label":"Reuters","publishedAt":"2026-07-22T00:00:00.000Z","notes":null,"title":null,"sourceName":"Reuters","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-23T13:22:08.470Z","updatedAt":"2026-07-23T13:22:08.470Z"}],"responses":[],"statusEvents":[{"id":"8bfc9735-333b-4900-994b-fd35d66f302e","incidentId":"0ef151fe-51d8-4706-af5e-37116f8cfd74","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-23T13:22:09.869Z","createdAt":"2026-07-23T13:22:09.869Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/fda-jj-ottava-denovo-jul2026","url":"https://registry.deploy.report/incidents/fda-jj-ottava-denovo-jul2026","headline":"FDA grants De Novo marketing authorization to J&J Ottava surgical robot","description":"On July 22, 2026, the FDA granted De Novo marketing authorization to Johnson and Johnson MedTech for its Ottava robotically-assisted surgical system, clearing the company to enter the US soft-tissue robotic surgery market. Ottava integrates robotic arms into the operating table, reducing footprint by 30-50 percent versus conventional cart-mounted systems. J&J plans a phased commercial launch with clinician training.","identifier":"0ef151fe-51d8-4706-af5e-37116f8cfd74","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":["secondary-established-publication"]}}}