{"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. 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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":[]}}}