On Jul. 22, 2026, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for the OTTAVA™ Robotic Surgical System, the world’s first table-integrated soft tissue robotic system. The system received marketing authorization for multiple procedures in general surgery, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.

Johnson & Johnson will commercially launch the OTTAVA system with select customers in the U.S., focusing on early customer success while working in parallel to advance into additional indications and regulatory jurisdictions over time. A U.S. clinical trial for OTTAVA in inguinal hernia procedures is ongoing.

OTTAVA is purpose-built to advance surgery today and where it goes next. Its unique architecture, automated features, next-generation robotic surgical instruments, and connection to an open digital ecosystem create a foundation to fit seamlessly into operating rooms today – and support more digitally enabled, data-driven surgery in the future.