Johnson & Johnson reported positive results from the first clinical study of its OTTAVA™ soft-tissue surgical robotic system. The company presented these findings at the 2026 American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting.
The multicenter study evaluated safety and performance in 30 patients undergoing Roux-en-Y gastric bypass procedures. The system met all primary safety and performance endpoints through 30 days post-procedure. Surgeons completed every procedure robotically without converting to non-robotic methods.
Johnson & Johnson submitted an application to the U.S. FDA for De Novo classification of the OTTAVA™ system. This submission incorporates both the clinical data and preclinical testing results.