Johnson & Johnson Wins FDA Authorization For OTTAVA Robotic Surgical System
(RTTNews) - Johnson & Johnson (JNJ) announced that the U.S. FDA has granted De Novo authorization for its OTTAVA Robotic Surgical System, the world's first table-integrated soft tissue robotic platform.
About the Authorization
The system has been cleared for use in multiple general surgery procedures, including gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.
Tim Schmid, Executive Vice President, Worldwide Chairman of MedTech, Johnson & Johnson, described OTTAVA as "The start of the next era in surgery," highlighting its potential to elevate surgical care through technology, clinical insight, and patient-focused design.
System Features
OTTAVA integrates robotic arms directly into the operating table, reducing footprint by 30-50% compared to traditional systems and enabling greater mobility for surgical teams.
Automated software coordinates four arms for simplified setup and breakdown, while synchronized table and arm motion allows seamless patient repositioning.
The system also introduces re-engineered surgical instruments, such as a two-in-one needle driver and monopolar curved scissors, designed to improve precision and consistency.
OTTAVA connects to Johnson & Johnson's Poluphonic digital ecosystem, providing surgical teams with data-driven insights, training, and continuous improvement tools.
Poluphonic is Johnson & Johnson's digital platform designed to integrate surgical data, enhance training, and support continuous performance across operating rooms.
Clinical Development
A U.S. clinical trial is ongoing to evaluate OTTAVA in inguinal hernia procedures, with Johnson & Johnson planning a phased commercial launch with select customers before expanding into additional indications and jurisdictions.
Johnson & Johnson emphasized that OTTAVA was designed to expand operating room capacity, streamline workflows, and improve access to robotic-assisted surgery. The company will host an investor call on August 3, 2026, to discuss the authorization and commercialization plans.
JNJ has traded between $164.23 and $269.43 over the past year. The stock closed Tuesday's trading at $250.61, up 0.72%. In pre-market trading the stock is at $252.94, up 0.91%.
