SANTA CLARA, Calif., United States – May 5, 2026
Johnson & Johnson has announced pivotal clinical study results for its investigational OTTAVA™ Robotic Surgical System, marking a significant milestone in the advancement of next-generation soft-tissue surgical robotics. The data, presented at the American Society for Metabolic and Bariatric Surgery Annual Meeting 2026, demonstrated that the system met its primary safety and performance endpoints in a 30-patient multicenter clinical study evaluating Roux-en-Y gastric bypass procedures, reinforcing its potential as a scalable and efficient robotic platform for complex surgeries. These findings support ongoing regulatory efforts, including a De Novo classification submission to the U.S. Food and Drug Administration, targeting broad use in upper abdominal general surgery procedures.
Clinical Study Confirms Safety and Performance
The clinical trial results showed that all procedures in the 30-patient cohort were successfully completed robotically using OTTAVA™, with no conversions to non-robotic approaches, a key indicator of system reliability and surgical feasibility. The study achieved its primary endpoints through 30 days post-procedure, with patients also demonstrating an average weight loss of 30 pounds, consistent with expected outcomes in bariatric surgery.
Conducted across six U.S. hospitals, the study evaluated real-world surgical performance, confirming that the system can safely and effectively support complex bariatric procedures. These findings are critical because robotic-assisted surgery must demonstrate both precision and reliability under clinical conditions, not just in controlled environments.
Novel Architecture Enables Broader OR Adoption
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A defining feature of the OTTAVA™ Robotic Surgical System is its table-integrated architecture, which incorporates four robotic arms directly into a standard surgical table, eliminating the need for bulky external robotic units or overhead booms. This design directly addresses a major limitation in robotic surgery, which is space constraints in operating rooms (ORs).
In the study, the system was successfully deployed in ORs ranging from 243 to 694 square feet, including spaces that were previously unsuitable for robotic surgery, demonstrating its ability to expand access to robotic-assisted procedures across a wider range of hospital settings. This is not just a design upgrade. It’s a practical solution to a real operational bottleneck that has limited robotics adoption in many healthcare facilities.
Strategic Advancement in Surgical Robotics
Johnson & Johnson is positioning OTTAVA™ as a multi-specialty robotic platform capable of supporting a wide range of procedures, including gastric bypass, gastric sleeve, small bowel resection, and hernia repair, aligning with the growing demand for minimally invasive and precision-guided surgical solutions. The system is currently being evaluated under the FORTE clinical study, a prospective, multicenter trial designed to generate robust clinical and performance data for regulatory approval.
While the system is still investigational and not yet commercially available, these results demonstrate strong potential for future adoption in general surgery and beyond, especially as healthcare systems increasingly prioritize efficiency, precision, and scalability in surgical care delivery. This milestone reflects a broader industry shift where robotic surgery is moving from niche use to mainstream clinical practice, driven by innovations that solve real-world limitations
Source: Johnson & Johnson press release
