The decision marks a key step for J&J's medtech business that had been seeking to compete in the robotic-assisted surgery market, currently dominated by Intuitive Surgical's (ISRG.O) da Vinci system. Medtronic's (MDT.N) Hugo robot was also approved last year.
J&J's Ottava robotic surgical system was authorized for use in multiple general surgery procedures in the upper abdomen, including gastric bypass, gastrectomy, gallbladder removal, gastric sleeve surgery, appendectomy and hiatal hernia repair.
The company said it would begin a U.S. commercial launch with select customers, while working on expanding the system into additional indications and regulatory markets.
The company said Ottava's robotic arms are integrated directly into the operating table, and therefore the device occupies 30% to 50% less space than traditional boom-and-cart-mounted systems used by most surgical robots.
J&J said its device has the potential to work in operating rooms that could not previously accommodate a robotic system.
Last week, J&J's medical device unit missed quarterly sales estimates after demand for its Impella heart pumps took a hit following the release of a UK study that raised questions about their use during certain high-risk coronary procedures.
