Johnson & Johnson has reported the first clinical study results for its OTTAVA Robotic Surgical System, a soft-tissue surgical robot tested in Roux-en-Y gastric bypass procedures for patients with obesity. The results represent a step in the company’s regulatory pathway, but they do not mean the system is commercially available. OTTAVA is currently not authorized for sale in any market.
The data come from the FORTE study, a prospective multicenter clinical trial in the United States. The study evaluated the safety and performance of OTTAVA in Roux-en-Y gastric bypass surgery, a bariatric procedure used in the treatment of obesity. According to Johnson & Johnson, all 30 procedures in the study were completed robotically using OTTAVA, without conversion to a non-robotic approach. The company said the study met its predefined safety and performance endpoints through 30 days after surgery.
The results were presented at the annual meeting of the American Society for Metabolic and Bariatric Surgery in San Antonio. Johnson & Johnson said the clinical data, together with preclinical testing, were used to support an application to the U.S. Food and Drug Administration for De Novo classification. The proposed indication covers several upper-abdominal general surgery procedures, including gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.
Robotic arms integrated into the operating table
OTTAVA differs from many existing surgical robots through its system architecture. The robot has four arms integrated into a standard-size surgical table. This contrasts with systems that use separate carts or an external boom positioned around the patient. Johnson & Johnson says this design could make robotic surgery easier to use in operating rooms where space is limited.
In the FORTE study, OTTAVA was installed and used in six hospitals. The operating rooms ranged in size from approximately 243 to 694 square feet. In five of the six sites, procedures were performed in rooms that had not previously been used for robotic surgery, including rooms that had been considered difficult for robotic systems because of space constraints.
For Johnson & Johnson, this is part of the positioning of OTTAVA as a multi-specialty soft-tissue surgical robot. The first clinical study focused on bariatric surgery, but the FDA application targets broader use in upper-abdominal general surgery.
Johnson & Johnson enters surgical robotics through its MedTech division
Although Johnson & Johnson is widely known as a pharmaceutical and healthcare company, OTTAVA is part of Johnson & Johnson MedTech. This division includes surgical instruments, orthopaedics, cardiovascular technology, vision products and digital surgical solutions. The robotics program is linked to the company’s broader surgical activities, including Ethicon.
Johnson & Johnson submitted OTTAVA to the FDA in January 2026. At that time, the company said the system was intended for use in upper-abdominal general surgery and that a second clinical study had been approved for inguinal hernia repair procedures.
The newly announced results move OTTAVA further along the regulatory pathway, but the final decision rests with the FDA. Until then, the system remains an investigational device.
