FDA grants De Novo authorization to J&J's OTTAVA surgical robot

The FDA granted De Novo marketing authorization to the OTTAVA Robotic Surgical System for upper-abdominal general surgery, including gastric bypass, gastrectomy, gallbladder removal, gastric sleeve and hiatal hernia repair. It is J&J's first soft-tissue surgical robot and opens a market that Intuitive Surgical's da Vinci dominates. J&J plans a U.S. commercial launch with select customers, and the robot's design places its four arms inside the operating table.

• De Novo authorization for upper-abdominal general surgery procedures
• Four robotic arms built into the operating table, which J&J says takes 30-50% less space than boom or cart systems
• U.S. launch planned first with select customers; an inguinal hernia trial is underway