Johnson & Johnson MedTech is touting positive results from the first clinical study of its Ottava soft-tissue surgical robot, showing the system can safely perform gastric bypass surgery.
J&J said Ottava met its primary safety and performance endpoints through 30 days post-procedure and that all the surgeries were completed robotically without the need to switch to a non-robotic approach.
J&J said it used the data, along with preclinical testing, to support its application to the FDA for de novo approval for the device for multiple upper abdominal surgeries, including gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.
The company unveiled the results at the 2026 American Society for Metabolic and Bariatric Surgery Annual Meeting.
“This is an exciting milestone for our program,” Hani Abouhalka, group chairman for surgery at J&J MedTech, said in a May 5 release.
He added that the outcome “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.”
The FORTE study included a cohort of 30 patients undergoing Roux-en-Y gastric bypass across six U.S. hospitals and followed them for 30 days after surgery.
The weight-loss procedure, which J&J said is increasingly being performed robotically, creates a smaller pouch within the stomach and connects it to the small intestine. The study found patients lost an average of 30 pounds by 30 days after the surgery.
The Ottava system was designed to take on Intuitive Surgical’s mainstay da Vinci robot as well as more recent challengers from Medtronic and CMR Surgical.
J&J has said the design allows it to fit within nearly any operating room, with four robotic arms that are integrated into a standard size surgical table, removing the need for a separate boom or carts.
For the study, the system was installed and used successfully in ORs that previously had been considered too small to accommodate robotic surgery, according to the release. OR sizes in the study ranged from roughly 243 to 694 square feet.
“At each step, from bench to preclinical to now human trial, we have observed that this system can allow more hospital ORs to accommodate robotics,” J&J MedTech Chief Scientific Officer Peter Schulam, M.D., said in a statement.
“These results demonstrate that the novel architecture can integrate into existing infrastructure and remove practical barriers to broader adoption.”
