Johnson & Johnson reports early clinical study results for investigational OTTAVA robotic surgical system

Johnson & Johnson announced results from the first clinical study of its investigational OTTAVA Robotic Surgical System, saying the device met its primary safety and performance endpoints in a 30-patient cohort undergoing Roux-en-Y gastric bypass procedures.

The findings were presented at the American Society for Metabolic and Bariatric Surgery 2026 annual meeting.

The prospective, multicenter clinical study evaluated the system’s safety and performance through 30 days after surgery. Investigators completed all procedures robotically using OTTAVA, with no cases requiring conversion to a non-robotic approach, according to the company.

Average weight loss among patients reached 30 pounds by 30 days after surgery.

The data, along with preclinical testing, were used to support an application to the U.S. Food and Drug Administration for De Novo classification. The application targets an indication covering multiple upper abdominal general surgery procedures, including gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.

“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 for the study. Wilson is chief of minimally invasive and elective general surgery at UTHealth Houston and director of bariatric surgery at Memorial Hermann-Texas Medical Center.

He said continued innovation in bariatric surgery is important to patient care and described the results as an initial step in evaluating the system.

Addressing bariatric surgery complexity

Johnson & Johnson said obesity remains widespread in the United States, with more than two in five adults affected. Metabolic and bariatric surgery procedures are considered effective long-term treatment options for weight loss management, the company said, noting that many such procedures are increasingly performed robotically.

Roux-en-Y gastric bypass, one of the procedures studied, is described as technically demanding compared with other bariatric surgeries. It involves both restrictive and reconstructive steps, typically spanning multiple abdominal quadrants and requiring a broad range of surgical tasks.

Hani Abouhalka, company group chair for surgery within Johnson & Johnson MedTech, called the study results an “exciting milestone” and said the work reflects the company’s long-term commitment to bariatric surgeons.

He added that the company aims to equip clinicians with a broad portfolio of surgical technologies across open, laparoscopic and robotic approaches to address the complexity of obesity care and expand access to precision surgical treatment.

System design and operating room integration

The OTTAVA system is designed as a multi-specialty soft-tissue surgical robot capable of supporting a wide range of procedures across clinical specialties.

Its architecture includes four robotic arms integrated into a standard-sized surgical table, eliminating the need for a separate boom or external carts.

According to the company, the system was successfully installed and used across operating rooms at all six participating hospitals in the study. The operating rooms ranged in size from approximately 243 to 694 square feet.

In five of the six study sites, procedures were performed in operating rooms that had not previously been used for robotic surgery. Some of these rooms were historically considered challenging for robotic systems due to space constraints.

Peter Schulam, chief scientific officer for Johnson & Johnson MedTech, said the company’s progress with OTTAVA™ is based on preclinical research, clinical data collection and collaboration with surgeons involved in the study.

He said the results demonstrate how the system’s architecture can integrate into existing hospital infrastructure and allow more operating rooms to accommodate robotic surgery, potentially reducing barriers to adoption.

About the FORTE study

The clinical trial, known as the FORTE study, is a single-arm, open-label evaluation conducted at six sites in the United States. Its purpose is to assess the safety and performance of the OTTAVA system through 30 days following Roux-en-Y gastric bypass surgery.

Data from the study, combined with preclinical findings, were included in the company’s FDA De Novo submission.

Johnson & Johnson said the OTTAVA Robotic Surgical System remains under development and is not currently authorized for marketing or sale in any market.