Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has granted De Novo authorization for its Ottava Robotic Surgical System, making it the world's first table-integrated soft tissue robotic surgical platform. The authorisation allows the system to be marketed for a broad range of general surgical procedures, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair.

The company plans to begin a phased commercial rollout of the Ottava system with select healthcare providers in the United States while continuing to expand its clinical applications and pursue regulatory approvals in additional global markets. A US clinical trial evaluating the system for inguinal hernia repair is currently underway.

Ottava has been designed to integrate seamlessly into existing operating room workflows through its unique architecture, which incorporates robotic arms directly into the operating table. According to Johnson & Johnson, the system occupies 30–50 percent less space than conventional boom- or cart-mounted robotic platforms, helping improve operating room efficiency and allowing greater mobility for surgical teams.

The platform also features automated setup capabilities, synchronised movement between the operating table and robotic arms, advanced robotic surgical instruments, and connectivity with the company's Polyphonic digital ecosystem, enabling data-driven surgical insights, workflow optimisation and continuous learning for clinicians.