FDA clears the first surgical robot built into the operating table — J&J's Ottava wins De Novo authorization

On 22 July 2026 the US Food and Drug Administration granted Johnson & Johnson MedTech De Novo authorization for Ottava, which the company describes as the world's first table-integrated soft-tissue robotic surgical system. De Novo is the pathway used when a device is novel enough that no cleared predecessor exists — the same route CMR's Versius took in 2024 — and it means the FDA had to define the device category rather than compare Ottava to something already on the market. The submission was filed on 7 January 2026, so the review ran roughly six and a half months. The design difference is structural: Ottava's four robotic arms sit inside the operating table rather than on carts or ceiling booms, which J&J says takes 30-50% less floor space. Its Twin-Motion architecture moves the table and the arms together, so a patient can be repositioned during a procedure without undocking, giving access across multiple quadrants of the abdomen. The authorization is narrower than the headline suggests. It covers ten named general-surgery procedures in the upper abdomen — Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair — and rests on the FORTE study, a 30-patient bariatric cohort that met its primary safety and performance endpoints at 30 days with no procedure converted away from the robot. Thirty patients is a small evidence base for a platform intended to serve multiple specialties, which is why the indication list matters more than the clearance itself. J&J is launching with select US customers rather than at volume, and has a separate US trial running in inguinal hernia repair under an IDE granted in late 2025. The competitive context is unforgiving: Intuitive's da Vinci platform passed 11,700 installed systems as of 30 June 2026.