On July 22, 2026, the FDA granted De Novo marketing authorization for Johnson & Johnson's OTTAVA Robotic Surgical System, marking its entry into the competitive soft-tissue robotics market. The table-integrated system features four robotic arms that occupy 30% to 50% less space than traditional systems. Authorized for upper abdominal surgeries like gastric bypass, the system will undergo a select U.S. commercial launch while clinical trials for inguinal hernia procedures continue.
OTTAVA FDA De Novo authorization
- ▪The U.S. Food and Drug Administration granted De Novo marketing authorization for Johnson & Johnson's OTTAVA Robotic Surgical System on July 22, 2026.
- ▪The regulatory clearance of the OTTAVA system followed a 30-person clinical trial demonstrating successful complex gastric bypass operations in all cases.
- ▪The OTTAVA system is authorized for multiple general surgery procedures in the upper abdomen, including gastric bypass, gastrectomy, gallbladder removal, gastric sleeve, appendectomy, and hiatal hernia repair.
Table-integrated robotic architecture
- ▪The table-integrated architecture of the OTTAVA system occupies 30% to 50% less space than traditional boom-and-cart-mounted surgical robotic systems.
- ▪The OTTAVA system integrates four robotic arms directly into the operating table, allowing them to fold down under the table when not in use.
Automated procedural setup features
- ▪The OTTAVA system features twin motion, which synchronizes the movement of the table and arms to provide patient repositioning and multi-quadrant anatomical access.
- ▪The OTTAVA system utilizes software controls to coordinate its four table-integrated arms, enabling automated, pre-defined procedural poses to simplify setup and breakdown.
Polyphonic digital ecosystem integration
- ▪The OTTAVA system is designed to integrate data and insights across the surgical ecosystem to support surgeon judgment and help improve patient outcomes.
- ▪The OTTAVA system connects to Polyphonic, a secure digital solution designed to bring learning, media, and data-driven insights together for surgical teams.
U.S. commercial launch strategy
- ▪Johnson & Johnson will begin a U.S. commercial launch of the OTTAVA system with select customers while working to expand into additional indications and regulatory markets.
- ▪Johnson & Johnson is currently conducting a U.S. clinical trial for the OTTAVA system in groin and inguinal hernia procedures.
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