A Robot Fused to the Table Just Cleared the F.D.A.

Johnson and Johnson's Ottava becomes the first table-integrated soft tissue surgical robot cleared in the U.S.

27 Jul 2026

Johnson and Johnson has received De Novo authorization from the Food and Drug Administration for its Ottava Robotic Surgical System, the first table-integrated soft tissue robotic platform cleared for use in the United States. The authorization covers a range of general surgery procedures in the upper abdomen, including gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.

Johnson and Johnson said Ottava's design, which fuses the operating table and robotic arms into one coordinated system, is meant to expand operating room capacity and simplify clinical workflows. Officials said the aim is to improve surgical performance without relying on separate cart-based components.

The authorization opens a competitive category that cart-based platforms had dominated until now. Industry analysts described the clearance as part of a broader wave of new robotic systems entering soft tissue surgery this year, as multiple companies advanced FDA submissions and clinical trials for next-generation platforms.

If adopted widely, systems built on Ottava's architecture are expected to extend robotic surgery into additional specialties over time. Those could include colorectal surgery, gynecology, thoracic surgery, and hepatobiliary procedures, analysts said.

For hospitals already building multi-platform robotics programs, the arrival of a table-integrated system introduces a distinct architectural choice alongside existing cart-based options. That choice carries implications for operating room layout and workflow design.

Administrators are likely to weigh integrated versus modular platform designs more carefully as future capital investment decisions come due. Analysts expect the calculus to shift again as more table-integrated systems reach the market.

Momentum in the category is unlikely to slow soon, executives close to the process said. Rivals are already said to be evaluating their own answers to Ottava's design.