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Johnson & Johnson reports clinical trial results for robotic surgery system

May 5, 2026 7:00 AM

Johnson & Johnson (NYSE: JNJ) announced results from the first clinical study of its investigational OTTAVA Robotic Surgical System at the 2026 American Society for Metabolic and Bariatric Surgery Annual Meeting. The prospective, multicenter study evaluated the system's safety and performance in Roux-en-Y gastric bypass procedures.

The study included 30 patients and met its primary safety and performance endpoints through 30 days post-procedure. Investigators completed all procedures robotically without conversion to non-robotic approaches. Patients averaged 30 pounds of weight loss by 30 days after surgery.

The OTTAVA system features four robotic arms integrated into a standard surgical table, eliminating the need for separate booms or carts. The study was conducted across six hospitals with operating room sizes ranging from approximately 243 to 694 square feet. Five of the six sites performed procedures in operating rooms that previously had not been used for robotic surgery.

"The data show encouraging evidence regarding the safety and performance of the OTTAVA Robotic Surgical System in Roux-en-Y gastric bypass procedures," said Erik Wilson, lead investigator and Chief of Minimally Invasive and Elective General Surgery at UTHealth Houston.

Johnson & Johnson used the clinical data and preclinical testing to support an application to the U.S. Food and Drug Administration for De Novo classification. The company is targeting an indication covering multiple procedures in general surgery within the upper abdomen, including gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.

The OTTAVA Robotic Surgical System is under development and is not authorized for marketing or sale in any market.

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