{"id":"8a5eca1b-77bc-445a-9fce-3301890f6c87","slug":"fda-de-novo-ottava-surgical-system-2026-07","kind":"regulatory_action","headline":"FDA grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures","summary":"The U.S. FDA granted De Novo marketing authorization to Johnson & Johnson's OTTAVA Robotic Surgical System, the world's first table-integrated soft tissue robotic system, on July 22, 2026. The clearance covers multiple general surgery procedures including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair. J&J plans a phased commercial launch with select U.S. customers.","occurredAt":"2026-07-22T12:00:00.000Z","reviewStatus":"reviewed","modelId":"97e94523-dc0c-45cf-be22-77e509e09e1b","deploymentId":"beb27823-63d3-42a5-aaf1-b8d762d29fd6","companyId":null,"dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","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":"2026-07-25T14:08:06.339Z","updatedAt":"2026-08-09T05:24:01.599Z","model":{"id":"97e94523-dc0c-45cf-be22-77e509e09e1b","companyId":"766676f2-56d0-4910-81dc-03703d6c9c40","modelName":"Johnson & Johnson Ottava","slug":"ottava-surgical","description":"Next-generation surgical robot in development by J&J/Ethicon. 6-arm configuration, general surgery focus.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.jnj.com/","title":"J&J","date_accessed":"2026-06-07"}],"aliases":[],"collisionRisk":"low","reviewNote":"reverified 2026-06-09 (Kimi-incident remediation): cited primary source resolves and matches manufacturer/reputable domain; relevance adjudicated.","manufacturerTermForTeleop":null,"keyFacts":[{"label":"Product","value":"MONATCH bronchoscopic robot, OTTAVA surgical robotics"},{"label":"Status","value":"Pre-market: FDA De Novo submitted Jan 7 2026; NOT cleared; zero installed base."},{"label":"Stock listing","value":"NYSE: JNJ"},{"label":"Developing division","value":"MedTech/Ethicon"},{"label":"Company type","value":"Global healthcare company"},{"label":"Revenue","value":"\\8B (2025, NYSE: JNJ)"}],"createdAt":"2026-06-08T00:59:22.195Z","updatedAt":"2026-07-12T04:24:54.291Z","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":{"id":"beb27823-63d3-42a5-aaf1-b8d762d29fd6","modelId":"97e94523-dc0c-45cf-be22-77e509e09e1b","versionId":null,"locationId":"fdf937a9-5eeb-4e8d-a514-ef860b351b30","operatorId":"766676f2-56d0-4910-81dc-03703d6c9c40","ownerId":null,"slug":"johnson-and-johnson-ottava-fda-clearance-2026","status":"announced","firstSeen":"2025-06-01T00:00:00.000Z","statusChangeReason":null,"contractType":null,"pilotOutcome":null,"endedAt":null,"unitsOnSite":null,"tasksPerformed":["surgical_assistance"],"shiftStructure":null,"hoursPerDay":8,"siteType":"hospital","operatorConfirmed":null,"humanSupervisionOnsite":null,"locationPrecisionTier":"verified_coordinates","deploymentScale":"undisclosed","siteEnvironment":"indoor","operatorType":"maker_operated","sourceQualityTier":2,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://seekingalpha.com/2026/07/22/jnj-ottava-fda","title":"Intuitive Surgical, Medtronic down as J&J wins FDA nod for surgical robot"}],"notes":"Johnson & Johnson won FDA clearance for Ottava surgical robot, new competitor to Intuitive Surgical. Intuitive Surgical and Medtronic stock both dropped on news.","keyFacts":[{"label":"FDA clearance","value":"Granted 2026"},{"label":"Competitor","value":"Intuitive Surgical da Vinci"}],"reviewNote":null,"exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":"healthcare","scaleTier":"undisclosed","contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-08-17T04:21:26.537Z","updatedAt":"2026-08-17T04:53:36.223Z"},"company":null,"derived":{"status":"active"},"sources":[{"id":"eebf8c93-ff29-42ed-8049-5d26a23c1a52","incidentId":"8a5eca1b-77bc-445a-9fce-3301890f6c87","url":"https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-market-authorization-in-the-u-s-for-its-ottava-robotic-surgical-system","label":"Johnson & Johnson","publishedAt":"2026-07-22T00:00:00.000Z","notes":null,"title":null,"sourceName":"Johnson & Johnson","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-25T14:08:06.339Z","updatedAt":"2026-07-25T14:08:06.339Z"},{"id":"8fefe878-5eca-4ff7-80b0-d49475b9f71d","incidentId":"8a5eca1b-77bc-445a-9fce-3301890f6c87","url":"https://www.massdevice.com/johnson-johnson-fda-approval-ottava-surgical-robot/","label":"MassDevice","publishedAt":"2026-07-22T00:00:00.000Z","notes":null,"title":null,"sourceName":"MassDevice","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-25T14:08:06.339Z","updatedAt":"2026-07-25T14:08:06.339Z"}],"responses":[],"statusEvents":[{"id":"3bfe4f9b-6529-4c7d-9b52-8fbb8932d064","incidentId":"8a5eca1b-77bc-445a-9fce-3301890f6c87","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-25T14:08:07.868Z","createdAt":"2026-07-25T14:08:07.868Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/fda-de-novo-ottava-surgical-system-2026-07","url":"https://registry.deploy.report/incidents/fda-de-novo-ottava-surgical-system-2026-07","headline":"FDA grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures","description":"The U.S. FDA granted De Novo marketing authorization to Johnson & Johnson's OTTAVA Robotic Surgical System, the world's first table-integrated soft tissue robotic system, on July 22, 2026. The clearance covers multiple general surgery procedures including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair. J&J plans a phased commercial launch with select U.S. customers.","identifier":"8a5eca1b-77bc-445a-9fce-3301890f6c87","datePublished":"2026-07-22T12:00:00.000Z","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":"verified","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":2,"primary_source_types":[]}}}