{"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. 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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":"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. 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