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OTTAVA, Johnson & Johnson's Robotic Entry Gains USFDA Clearance
24 July 2026
The U.S. Food and Drug Administration has granted a De Novo approval for Johnson & Johnson (J&J) to market OTTAVA* their long-anticipated entry into the robotic surgery category. The USFDA De Novo approval means that J & J has proven that the device has met preliminary trial standards for safety as a unique product in the market with no equivalent.
Image source: www.jnjmedtech.com
From the J & J July 22, 2026, press release: “We are pioneering a new category of surgical robotics with OTTAVA,” said Tim Schmid, Executive Vice President, Worldwide Chairman, MedTech, Johnson & Johnson. “This is the start of the next era in surgery as we deliver not just a new surgical robotics system, but a catalyst for fundamentally better surgical care that is informed by technology, guided by clinical insight, and delivered with care by Johnson & Johnson.”
The device is contained on a surgical table, with four independent arms, which can be stowed below the table. The company claims that the system footprint is 34% smaller that Intuitive Surgical's da Vinci. J & J's press release reports: "The system received marketing authorization for multiple procedures in general surgery, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair." The company is seeking further procedural clearances through trials currently underway.
For more information, please visit the J & J website: https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-market-authorization-in-the-u-s-for-its-ottava-robotic-surgical-system
*OTTAVA is a trademark of Johnson & Johnson.