NEW BRUNSWICK, N.J., July 22, 2026
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for the OTTAVA™ Robotic Surgical System, making it the world’s first table-integrated soft tissue robotic surgical platform authorized for use in the United States. The system is approved for multiple general surgery procedures involving the upper abdomen, including gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, fundoplication, hiatal hernia repair, and lysis of adhesions. Johnson & Johnson plans to begin a phased commercial launch with select U.S. healthcare providers while continuing clinical development in additional surgical indications, including an ongoing U.S. clinical trial for inguinal hernia repair.
FDA Authorization Establishes New Category in Soft Tissue Robotics
OTTAVA introduces a new category of robotic-assisted surgery through its unique architecture that integrates four robotic arms directly into the operating room table, eliminating the need for traditional floor-mounted robotic carts. According to Johnson & Johnson, the system occupies 30% to 50% less operating room space than conventional multi-port robotic systems, allowing greater flexibility for surgical teams while supporting more efficient operating room workflows. The FDA’s De Novo authorization recognizes OTTAVA as a novel medical technology designed to improve robotic-assisted surgery through enhanced automation, streamlined setup, and integrated surgical workflow management.
Advanced Automation and Digital Connectivity Enhance Surgical Workflows
The OTTAVA platform incorporates automated procedural positioning, synchronized table and robotic arm movement, and multi-quadrant anatomical access designed to reduce intraoperative adjustments during surgery. The system also features a new generation of robotic surgical instruments, including an integrated two-in-one needle driver and optimized monopolar curved scissors intended to improve surgical precision and efficiency. In addition, OTTAVA connects to Johnson & Johnson’s Polyphonic™ digital ecosystem, providing surgeons and hospitals with secure access to procedural data, educational resources, surgical media, and analytics that support continuous clinical improvement and future data-driven surgical decision-making.
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Commercial Rollout Begins as Johnson & Johnson Expands Robotic Surgery Portfolio
Johnson & Johnson will initially introduce OTTAVA through a limited commercial launch with select U.S. hospitals to support early clinical adoption before expanding availability to additional healthcare institutions and international markets. Alongside commercialization, the company will continue developing new surgical indications and regulatory approvals while offering comprehensive surgeon education programs that combine virtual learning, hands-on training, and immersive simulation. Company executives stated that OTTAVA represents the next generation of robotic-assisted surgery by combining advanced robotics, automation, digital connectivity, and surgical intelligence to improve operating room efficiency and expand patient access to minimally invasive surgical care.
Source: Johnson & Johnson, press release
