J&J Wins FDA De Novo OTTAVA System

Johnson & Johnson has received FDA De Novo authorization for Ottava, its table-integrated soft-tissue robotic system, enabling marketing for several general surgery procedures in the United States and positioning J&J to compete with Intuitive Surgical’s da Vinci system. The device is designed to occupy substantially less space than traditional robotic setups, with a setup that integrates four robotic arms into the operating table and features twin motion for synchronized table and arm movements. J&J plans a U.S. commercial rollout with select customers while pursuing expanded indications and international approvals, and is conducting an ongoing U.S. clinical study for inguinal hernia procedures. The Ottava platform connects to a secure digital ecosystem for training and data insights, and includes updated instrumentation to support precise, streamlined surgical workflows. Market and investor interest have been noted, with J&J publicly highlighting its medtech strategy and ongoing development of Ottava beyond the initial indications. Overall, Ottava marks a significant step for J&J into the increasingly competitive robotic surgery market, complementing its broader push in medical technology innovations.