Johnson & Johnson (J&J) is eyeing a De Novo classification from US regulators for its Ottava Robotic Surgical System, after the device met its key goals in a prospective gastroenterology study.
During the single-arm, open-label FORTE trial (NCT06709261), 30 patients across six US sites were given Roux-en-Y gastric bypass (RYGB) with the Ottava system, with outcomes monitored for 30 days after the procedure. RYGB is performed to reduce the capacity of a patient’s stomach, which is designed to restrict food intake and promote weight loss for those with obesity.
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After the observation period, patients lost an average of 30 pounds (13.6kg) post-surgery, with Ottava meeting all of its primary safety and performance-based endpoints. Though J&J is yet to release more details on this study, the New Jersey-based pharma did note that this result, plus preclinical data, has been used in its De Novo application to the US Food and Drug Administration (FDA).
If J&J secures De Novo classification for the Ottava system, it could be used to cover multiple gastrointestinal procedures – including gastric bypass and sleeve-based surgeries, as well as small bowel resection, hiatal hernia repair and general upper abdominal surgeries.
J&J designed the Ottava system to perform soft tissue surgeries across a range of speciality areas, incorporating four robotic arms built into a standard size surgical table.
According to Peter Schulam, J&J’s CSO for medtech, the FORTE trial results demonstrate that Ottava can be integrated into existing hospital infrastructure, which could “remove practical barriers to broader adoption” of robotics in healthcare settings that may have previously been too small for these types of solutions.
J&J presented results from the FORTE study as an abstract at the 2026 American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting. The meeting is currently ongoing in San Antonio, Texas.
Robotic surgeries take off
The positive results for the FORTE study come as robotic surgeries become increasingly incorporated into hospitals worldwide.
Currently, Intuitive Surgical is the top earner in this field, holding 60.1% of the market share via its da Vinci surgical robot system, which has experienced widespread uptake due to a “strong installed base, surgeon training programmes and continuous innovation,” GlobalData analyst Graysen Vigneux previously told Medical Device Network.
However, other companies are looking to absorb a portion of Intuitive’s market share, with J&J securing 510(k) clearance from the FDA for its robotic-assisted bronchoscopy device, MONARCH QUEST, back in March 2025.
J&J’s subsidiary DePuy Synthes, which recently spun out amid the former’s portfolio slimming strategy, also markets the VELYS Active Robotic-Assisted System for use in spinal surgeries. This technology debuted in the US in August 2024.
While medtech companies continue to explore the promise of surgical robots, a report from GlobalData predicts that remote-enabled surgical robotics is entering a pivotal growth phase. This comes as next-generation platforms use teleoperation, advanced imaging and high-speed connectivity – potentially expanding their clinical reach.
