Johnson & Johnson (J&J) has secured FDA approval for its Ottava surgical robot system, a significant milestone after over a decade of research and development, and years of delays. This approval positions J&J to enter the rapidly growing surgical robotics market, which has historically been dominated by Intuitive Surgical's da Vinci system, holding approximately 80% market share.
The Ottava system is designed to advance soft tissue surgery with a unique architecture that integrates four robotic arms into a standard-size surgical table, stowing them beneath when not in use. This "invisible design" allows Ottava to occupy 30-50% less space compared to traditional boom- and cart-mounted robotic systems. The system also features sophisticated software controls for automated procedural poses, twin motion capabilities for seamless patient repositioning, and optimized instrumentation, including a two-in-one needle driver and monopolar curved scissors.
J&J plans a controlled commercial launch with select U.S. customers, focusing on early success before expanding to additional indications and regulatory jurisdictions. The FDA authorization covers multiple general surgery procedures, such as Roux-en-Y gastric bypass, gastrectomy, and hiatal hernia repair. The company is also conducting a U.S. clinical trial for Ottava in inguinal hernia procedures and has connected the system to its Polyphonic digital ecosystem for continuous improvement through learning, media, and data-driven insights. The FDA's green light for Ottava marks the second major surgical robot approval in the last year, following Medtronic's Hugo system for urologic procedures in late 2025.
