Johnson & Johnson received U.S. Food and Drug Administration marketing authorization for its OTTAVA robotic surgical system on July 22, marking the company's entry into the soft-tissue robotic surgery market1,9,12.
The FDA granted clearance through the De Novo regulatory pathway, which applies to novel medical devices without an existing predicate. The authorization covers 10 types of general surgery procedures in the upper abdomen, including gastric bypass, gastrectomy, cholecystectomy, splenectomy, appendectomy, and hiatal hernia repair.
Johnson & Johnson described OTTAVA as the world's first table-integrated soft-tissue surgical robot system. The device features four robotic arms built directly into the operating table, which fold down under the table when not in use. The company said the integrated design allows OTTAVA to occupy 30% to 50% less space than traditional boom-and-cart-mounted surgical robot systems.
The regulatory clearance followed a 30-person clinical trial that showed complex gastric bypass operations could be completed successfully with the robot in all cases. Another trial in groin hernia surgery is currently ongoing.
"We are pioneering a new category of surgical robotics with Ottava," said Tim Schmid, executive vice-president and worldwide chairman of medtech at Johnson & Johnson.
Johnson & Johnson said it plans to begin a phased commercial rollout of OTTAVA with select healthcare providers in the United States, with plans to improve the system based on feedback from initial adoption before expanding supply to other hospitals and overseas markets. The company submitted its FDA application for OTTAVA in early January and has spent billions since 2015 developing and acquiring robotic technology.
The approval places Johnson & Johnson in direct competition with Intuitive Surgical, whose da Vinci system has dominated the soft-tissue surgical robot market. As of June, Intuitive Surgical had 11,395 da Vinci systems installed in hospitals worldwide and installed 431 units in the first quarter alone. Intuitive Surgical's second-quarter 2026 revenue rose 18.5% year over year to $2.89 billion. The da Vinci system has been used in millions of surgeries since Intuitive Surgical brought its first robot to market in 2000.
Medtronic also entered the U.S. robotic surgery market after its Hugo system was cleared for urologic surgery in 2025. CMR Surgical's device received its first U.S. authorization for gallbladder operations in 2024.
ANALYSIS OTTAVA's table-integrated design and space-efficiency claims represent a differentiated engineering approach compared to existing cart-based systems, though the initial clearance is limited to upper abdominal procedures — a narrower scope than the full range of soft-tissue surgeries where da Vinci has established dominance over more than two decades. The phased rollout strategy means competitive impact on Intuitive Surgical's installed base will take time to materialize.