Johnson & Johnson has received FDA De Novo authorization for its OTTAVA Robotic Surgical System, marking the company's first U.S. regulatory clearance for a soft-tissue surgical robot1,2.
The FDA cleared OTTAVA for several general surgical procedures, including gastric bypass, sleeve gastrectomy, gallbladder removal, appendectomy, and hiatal hernia repair. The authorization 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.
OTTAVA is described as the world's first table-integrated soft-tissue surgical robot, with four robotic arms built directly into the operating table. The arms fold down under the table when not in use. Johnson & Johnson says this design reduces the system's operating room footprint by 30% to 50% compared to other systems, allowing hospitals to optimize space while improving surgical workflow.
The approval comes after more than a decade of research and development. Johnson & Johnson has spent billions since 2015 developing and acquiring robotic technology. J&J executives said OTTAVA was designed to be capable of performing all the major types of procedures that robotic surgery is used for today.
Johnson & Johnson plans to begin a phased commercial rollout with select healthcare providers in the United States before expanding to additional hospitals, surgical specialties, and international markets.
The authorization positions Johnson & Johnson against established competitors in the robotic surgery market. Intuitive Surgical brought its first robot to market in 2000 and has more than 11,000 systems installed worldwide. Medtronic's Hugo robot was cleared for urologic surgery in the U.S. in 2025, and CMR Surgical's device received its first U.S. authorization for gallbladder operations in 2024.
ANALYSIS OTTAVA's table-integrated design and its clearance across multiple procedure types — rather than a single surgical category — differentiate it from competitors that received narrower initial authorizations. The phased rollout strategy, however, means the system's competitive impact will depend on how quickly Johnson & Johnson can scale installations against Intuitive Surgical's deeply entrenched installed base.