J&J OTTAVA Robotic System FDA Authorization

Johnson & Johnson received FDA De Novo marketing authorization for its OTTAVA Robotic Surgical System, the first table-integrated soft tissue robotic system. The system is cleared for multiple general surgery procedures in the upper abdomen, including gastric bypass, gastrectomy, cholecystectomy, and hiatal hernia repair. J&J plans a phased U.S. commercial launch with select customers and aims to expand into additional indications and global markets like Japan and Western Europe. The OTTAVA system features a smaller footprint (30-50% less space than traditional systems), automated arm coordination, and integration with J&J's Polyphonic digital ecosystem. Analysts note that while OTTAVA offers unique advantages, it faces strong competition from Intuitive Surgical's da Vinci system and Medtronic's Hugo robot. A clinical trial for inguinal hernia repair is ongoing, with potential for a second FDA submission early next year. J&J will host an investor call on August 3, 2026.