Johnson & Johnson has received US Food and Drug Administration De Novo marketing authorisation for its OTTAVA robotic surgical system.

The company describes OTTAVA as the first table-integrated robotic system authorised for soft-tissue surgery. Its robotic arms are incorporated into the operating table and can be stowed beneath it when not in use.

The system has been authorised for multiple general surgery procedures involving the upper abdomen. These include Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve surgery, small-bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair.

Johnson & Johnson developed the system to allow the patient and robotic arms to be repositioned together without undocking during surgery. The table-integrated configuration is also intended to provide surgical teams with greater access to the patient and reduce the amount of equipment occupying the operating room.

The system incorporates Ethicon surgical instruments and a surgeon console designed to provide control over the robotic arms, surgical instruments and visualisation platform.

The De Novo authorisation establishes a new regulatory classification for the system and provides a pathway for future devices with similar intended uses.

Johnson & Johnson said it will begin a limited US commercial launch with selected hospitals before expanding availability more broadly.