Johnson & Johnson said the FDA has granted De Novo marketing authorization for its OTTAVA robotic surgical system, clearing the platform for use in multiple soft tissue general surgery procedures in the United States.

The New Brunswick, New Jersey-based company said the authorization covers procedures including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, sleeve gastrectomy, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair.

Johnson & Johnson plans a limited commercial rollout with select U.S. hospitals while it pursues additional indications and regulatory approvals in other markets. The company also said a U.S. clinical trial evaluating the system for inguinal hernia repair remains underway.
OTTAVA is distinguished by robotic arms integrated into the operating table rather than mounted on separate carts or booms. According to Johnson & Johnson, the design reduces the system's footprint by 30% to 50% compared with conventional multiport soft tissue robotic platforms, potentially creating more space in the operating room.

The company said the system includes four coordinated robotic arms with automated setup and positioning features, as well as "twin motion", which synchronizes movement of the operating table and robotic arms to reposition patients during surgery while maintaining access to the surgical field.

Johnson & Johnson also introduced a new portfolio of robotic instruments for the platform and said OTTAVA connects with its Polyphonic digital ecosystem, which provides training resources, media management and procedural data.

"Robotic surgery has helped expand access to minimally invasive techniques for many patients, but we must continue pushing the field forward," said Dr. Erik Wilson, chief of minimally invasive and elective general surgery at UTHealth Houston and director of bariatric surgery at Memorial Hermann-Texas Medical Center. "This milestone is meaningful because it adds a new voice, a new perspective and a novel approach to the ongoing evolution of robotic surgery, which is an area of opportunity for hospitals today."

The authorization marks Johnson & Johnson's entry into the soft tissue surgical robotics market with a platform designed to compete in a segment that has been led by Intuitive Surgical's da Vinci systems. FDA De Novo authorization establishes a new regulatory classification for novel medical devices that do not have a substantially equivalent legally marketed predicate.

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