Johnson & Johnson (J&J) has received marketing authorization from the US Food and Drug Administration (FDA) for its Ottava robotic surgical system, clearing its entry into the US soft-tissue robotic surgery market. The approval is an important milestone as J&J seeks to challenge Intuitive Surgical, whose da Vinci system dominates the field; Medtronic’s Hugo surgical robot was approved last year. Ottava has been authorized for several general surgery procedures involving the upper abdomen, including gastric bypass, gastrectomy, gallbladder removal, gastric sleeve surgery, appendectomy and hiatal hernia repair. J&J said it would initially introduce Ottava to select customers in the United States and plans to seek approval for additional procedures and expand into more international markets, including Japan and Western Europe. According to Hani Abouhalka, chairman of surgery at J&J MedTech, robotic systems are currently used in only about 8% of surgical procedures worldwide. J&J said Ottava’s robotic arms are integrated directly into the operating table, occupying 30% to 50% less space than traditional boom-and-cart-mounted systems, potentially allowing installation in operating rooms that could not previously accommodate a robotic system. However, analysts noted J&J faces a difficult challenge in dislodging Intuitive Surgical.