Johnson & Johnson Receives FDA Market Authorization in the U.S. for its OTTAVA™ Robotic Surgical System

Johnson & Johnson recently secured FDA marketing authorization for the OTTAVA Robotic Surgical System. This platform represents a new approach to soft tissue robotics, as it is the first system to feature table integration. By embedding robotic arms directly into the operating table, the design reduces the physical footprint of the equipment by 30 to 50 percent compared to traditional cart-based models. This change aims to provide surgical teams with more room to move and communicate during procedures.

The system is cleared for a range of general surgery applications in the upper abdomen. Authorized procedures include gastric bypass, gastrectomy, and cholecystectomy, along with several types of hernia repair. The software coordinates the four integrated arms to simplify setup and breakdown through automated procedural poses. Furthermore, the system includes a synchronized motion feature that allows the table and arms to move together, which supports better access to patient anatomy.

Technological integration remains a central priority for this new platform. The system connects to the Polyphonic digital ecosystem, which provides surgical teams with access to data and media to support training and clinical workflows. Instrumentation has also undergone a redesign, featuring tools like a specialized two-in-one needle driver to prevent suture cutting and scissors optimized for consistent performance.

Commercial rollout begins with select U.S. customers while the company continues to work on expanding to further indications and regulatory markets. A clinical trial for inguinal hernia procedures is already underway. Johnson & Johnson plans to host an investor conference call on August 3, 2026, to discuss the rollout and the future of their surgical robotics sector.