Johnson & Johnson MedTech said the investigational OTTAVA Robotic Surgical System met its primary safety and performance endpoints in a 30-patient Roux-en-Y gastric bypass study, marking the platform's first reported pivotal clinical data and a key step toward FDA review.
What The FORTE Study Showed
The FORTE study (NCT06709261) is a single-arm, multi-center evaluation conducted at six U.S. sites. All 30 procedures were completed robotically on OTTAVA, with no conversions to laparoscopic or open surgery, and patients lost an average of about 30 pounds within 30 days post-procedure, J&J said in a May 5, 2026 statement. The abstract was presented at the American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting in San Antonio.
OTTAVA's distinguishing feature is a "table-integrated" architecture: four robotic arms are mounted directly to a standard-size surgical table, removing the need for a separate boom or carts. In five of six study sites, the system was installed in operating rooms that had never previously hosted a robotic surgery program.
The FDA Path
J&J said the FORTE data, combined with preclinical testing, supported a De Novo classification application to the U.S. Food and Drug Administration covering multiple general surgery indications in the upper abdomen, including gastric bypass, sleeve gastrectomy, small bowel resection and hiatal hernia repair. OTTAVA remains investigational and is not yet authorized for sale in any market.
The Race To Take On Intuitive
OTTAVA is one of several next-generation soft-tissue systems racing to challenge Intuitive Surgical's da Vinci dominance. Other medtech players have been moving fast in adjacent imaging and surgical AI, while CMR Surgical's Versius Plus secured FDA clearance late last year and Medtronic's Hugo received FDA clearance for urology procedures. J&J's table-integrated design is a deliberate bet that hospitals will favor robots that fit existing ORs rather than dedicated suites.
For J&J's MedTech business, OTTAVA represents one of the most strategic robotics bets in its surgery portfolio and a critical pillar of the company's long-term growth plan in interventional medicine.
Reporting based on coverage from Johnson & Johnson's May 5, 2026 press release and MedTech Dive.