Johnson & Johnson's OTTAVA Robotic Surgical System Meets Pivotal Study Endpoints in Gastric Bypass Trial
J&J's table-integrated OTTAVA robot completed all 30 gastric bypass procedures without conversion and met safety endpoints, advancing its FDA De Novo application.
Overview
Johnson & Johnson announced on May 5, 2026, that its investigational OTTAVA™ Robotic Surgical System met the primary safety and performance endpoints of the FORTE clinical study, a prospective, multicenter evaluation of the system in Roux-en-Y gastric bypass procedures, according to a press release published on BioSpace. Results were presented at the 2026 American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting in San Antonio, Texas.
What We Know
The FORTE study (NCT06709261) enrolled 30 patients across six U.S. hospital sites and evaluated OTTAVA in Roux-en-Y gastric bypass surgery over a 30-day follow-up period. According to BioSpace, all procedures were completed robotically on OTTAVA without conversion to a non-robotic approach, and patients lost an average of 30 pounds within 30 days of surgery.
A distinctive feature of the trial was where the procedures took place. In five of the six participating hospital sites, surgeries were performed in operating rooms that previously had not been used for robotic procedures — including rooms historically considered too small for robotic systems. The participating ORs ranged in size from approximately 243 to 694 square feet, according to BioSpace.
OTTAVA’s architecture underpins this space flexibility: the system integrates four robotic arms directly into a standard surgical table, eliminating the separate boom or cart structures common to other platforms.
Erik Wilson, M.D., Chief of Minimally Invasive and Elective General Surgery at UTHealth Houston and Director of Bariatric Surgery at Memorial Hermann-Texas Medical Center, served as lead investigator. Wilson said the data offer encouraging early evidence: “The data show encouraging evidence regarding the safety and performance of the OTTAVA™ Robotic Surgical System in Roux-en-Y gastric bypass procedures. Continued innovation in bariatric surgery is important to patient care, and I am pleased to present these initial clinical results,” according to BioSpace.
Hani Abouhalka, Company Group Chair for Surgery at J&J MedTech, framed the FORTE results as a significant program milestone: “This is an exciting milestone for our program as we share the role of OTTAVA™ as a robotic surgical system with a novel architecture supporting patient treatment during the clinical trial. This work also underscores our long-term commitment to bariatric surgeons and to equipping clinicians with a broad portfolio of surgical technologies to address the complexity of obesity care. Across open, laparoscopic, and robotic surgery, we remain focused on translating innovation into real-world solutions that help surgeons broaden access to precision surgical care and improve outcomes for patients,” per BioSpace.
Peter Schulam, M.D., Ph.D., Chief Scientific Officer of J&J MedTech, said the results validate the table-integrated design in real clinical settings: “These results demonstrate that the novel architecture can integrate into existing infrastructure and remove practical barriers to broader adoption,” according to BioSpace.
Regulatory Pathway
The FORTE clinical data underpin J&J’s application to the U.S. Food and Drug Administration for De Novo classification, which the company submitted on January 8, 2026, according to BioSpace. The De Novo pathway allows novel devices that pose low to moderate risk to reach the market without a predicate, creating a new device classification. The submission targets multiple upper abdominal procedures: gastric bypass, gastric sleeve, small bowel resection, and hiatal hernia repair. A separate Investigational Device Exemption has been approved for inguinal hernia procedures, according to BioSpace.
The OTTAVA system integrates with J&J’s Polyphonic™ digital surgery ecosystem and uses Ethicon-powered instrumentation, according to the same source. The system is not yet authorized for marketing or sale in any market.
What We Don’t Know
The FORTE study was a 30-patient, single-arm trial evaluated over 30 days — a design that establishes early safety and performance signals but does not supply the controlled, longer-term data typically required for a broad surgical indication. The FDA has not indicated a timeline for its De Novo review.
The trial covered only Roux-en-Y gastric bypass, while the De Novo submission targets a broader set of procedures including gastric sleeve, small bowel resection, and hiatal hernia repair. Data for those additional indications has not been made public.
Analysis
The surgical robotics market has grown increasingly competitive in the first half of 2026. CMR Surgical launched its Versius Plus system in the United States in April, as previously reported, and Medtronic’s Hugo received its first U.S. FDA clearance for a urologic indication in late 2025. The OTTAVA system aims for a differentiated position through its table-integrated architecture, which J&J argues makes it compatible with a broader range of hospital infrastructure than cart- or boom-mounted alternatives.
Obesity remains a major public health challenge: more than two in five adults in the United States have obesity, according to BioSpace, creating persistent demand for safe, scalable bariatric interventions. The ability to bring robotic surgery into operating rooms that previously lacked it could expand access beyond the large academic medical centers where robotics have historically been concentrated.
The FORTE results do not resolve questions about how OTTAVA will perform across its broader target indication set, or how its learning curve and workflow will compare with established platforms. The De Novo review process will determine whether the FORTE evidence base is sufficient for commercial authorization.