{"id":"d78c50a9-6fd6-4296-9254-9f66d2360efb","companyId":"766676f2-56d0-4910-81dc-03703d6c9c40","modelName":"Ottava","slug":"jnj-ottava","description":"Johnson & Johnson (NYSE: JNJ; founded 1886, New Brunswick, New Jersey), through its MedTech and Ethicon division, is developing Ottava, a soft-tissue general-surgery robotic platform with a unified architecture of four arms integrated into the operating table, announced in 2020 and repeatedly delayed. The critical audit finding is that as of mid-2026 Ottava is pre-market: J&J submitted it to the FDA via a De Novo classification application on January 7, 2026 for multiple upper-abdomen general-surgery procedures, and the company's own language states it is under development and not authorized to be marketed or sold in any market. Investigational first cases were completed in early 2025 at Memorial Hermann in the Texas Medical Center, with a second investigational study for inguinal hernia approved in late 2025. The registry records Ottava at research maturity, because under the verified-vs-claimed framework no regulatory clearance means research-tier regardless of corporate scale or demonstrations, and Ottava has no clearance and zero installed base, only investigational-trial cases. An aggregator claim that Ottava was targeted for commercial launch in late 2025 or early 2026 is contradicted by the primary J&J source and is not registered. For context, J&J's separate Monarch robotic bronchoscopy, acquired through Auris in 2019, and its Velys robotic knee-replacement system are already FDA-cleared commercial products, but Ottava is the soft-tissue surgical-robot entity and remains pre-market.","formFactor":"surgical","maturityStage":"research","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"Verified (pre-market)","value":"Johnson & Johnson (NYSE: JNJ; founded 1886, New Brunswick NJ; MedTech/Ethicon division) submitted Ottava to the FDA via a De Novo classification application on Jan 7 2026 for multiple upper-abdomen general-surgery procedures. J&J's own language: Ottava 'is under development and is not authorized to be marketed or sold in any market.' IDE first cases completed early 2025 at Memorial Hermann-Texas Medical Center; a second IDE (inguinal hernia) approved late 2025."},{"label":"Maturity = research (FDA gating not cleared)","value":"Per the framework, NO clearance = research-tier regardless of corporate scale or demos. Ottava has an active IDE and a pending De Novo submission but no clearance and ZERO installed base / zero approved procedures (IDE-trial cases only)."},{"label":"Aggregator-drift correction","value":"A secondary source claimed Ottava was 'targeted for commercial launch late 2025 / early 2026.' CONTRADICTED by the primary J&J source (De Novo submitted Jan 7 2026; explicitly not marketable). Do NOT register a launch date. 'Breakthrough device designation' (secondary) is unverified against primary records."},{"label":"Adjacent J&J robotics (context, not this entity)","value":"Monarch (robotic bronchoscopy, via the 2019 $3.4B Auris acquisition; FDA-cleared; competes with Intuitive Ion) and Velys (robotic knee replacement, FDA-cleared Mar 2021) are separate commercial J&J robotics products."}],"products":"Ottava: J&J MedTech (Ethicon) soft-tissue general-surgery robotic platform, four arms integrated into the operating table; announced 2020. NOT cleared, NOT marketed.","formFactor":"surgical (unified-architecture four-arm soft-tissue general-surgery robot; arms integrated into the table)"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-ottava-robotic-surgical-system-to-the-u-s-food-and-drug-administration","title":"J&J submits Ottava to FDA (De Novo, Jan 7 2026; 'not authorized to be marketed')","sourceName":"Johnson & Johnson (official)"},{"url":"https://www.medtechdive.com/news/jnj-layoffs-auris-california-robotic/644544/","title":"J&J robotics layoffs + Ottava delays (history/context)","sourceName":"MedTech Dive"},{"url":"https://www.fiercebiotech.com/medtech/jj-to-take-over-verb-surgical-its-robotics-venture-verily","title":"J&J takes over Verb Surgical (Ottava lineage)","sourceName":"FierceBiotech"}],"aliases":["Ottava","J&J Ottava","Ethicon Ottava"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"createdAt":"2026-06-03T20:12:18.862Z","updatedAt":"2026-06-03T20:12:18.862Z","jsonLd":{"@context":"https://schema.org","@type":"Product","@id":"https://registry.deploy.report/models/jnj-ottava","url":"https://registry.deploy.report/models/jnj-ottava","name":"Ottava","alternateName":["Ottava","J&J Ottava","Ethicon Ottava"],"description":"Johnson & Johnson (NYSE: JNJ; founded 1886, New Brunswick, New Jersey), through its MedTech and Ethicon division, is developing Ottava, a soft-tissue general-surgery robotic platform with a unified architecture of four arms integrated into the operating table, announced in 2020 and repeatedly delayed. The critical audit finding is that as of mid-2026 Ottava is pre-market: J&J submitted it to the FDA via a De Novo classification application on January 7, 2026 for multiple upper-abdomen general-surgery procedures, and the company's own language states it is under development and not authorized to be marketed or sold in any market. Investigational first cases were completed in early 2025 at Memorial Hermann in the Texas Medical Center, with a second investigational study for inguinal hernia approved in late 2025. The registry records Ottava at research maturity, because under the verified-vs-claimed framework no regulatory clearance means research-tier regardless of corporate scale or demonstrations, and Ottava has no clearance and zero installed base, only investigational-trial cases. An aggregator claim that Ottava was targeted for commercial launch in late 2025 or early 2026 is contradicted by the primary J&J source and is not registered. For context, J&J's separate Monarch robotic bronchoscopy, acquired through Auris in 2019, and its Velys robotic knee-replacement system are already FDA-cleared commercial products, but Ottava is the soft-tissue surgical-robot entity and remains pre-market.","identifier":"d78c50a9-6fd6-4296-9254-9f66d2360efb","category":"surgical","publisher":{"@id":"https://deploy.report/#organization"}}}