Dive Brief:
- Johnson & Johnson said Wednesday it has submitted its Ottava soft tissue robotic surgery system to the Food and Drug Administration for de novo classification in general surgery. The company has applied for marketing authorization in multiple procedures within the upper abdomen.
- The application is supported by data from the company’s investigational device exemption study in Roux-en-Y gastric bypass, a type of weight-loss surgery that creates a small pouch from the stomach to reroute food to the small intestine.
- J&J said it also received IDE approval in late 2025 to begin a U.S. clinical trial to study Ottava in inguinal hernia procedures, one of the most common surgeries in the U.S.
Dive Insight:
The FDA submission for Ottava follows Medtronic’s U.S. clearance in December for its Hugo robotic surgery system in urologic procedures. The two leaders in surgical instrument manufacturing will challenge Intuitive Surgical’s decades-long dominance in the robot-assisted soft tissue surgery market.
“We have taken learnings from Johnson & Johnson’s 140 years in surgery, our decades of leadership in minimally invasive surgery, and the experiences robotic surgeons and hospitals have had over the past 20 years to design a soft tissue robotic system built for the future of surgery,” Hani Abouhalka, company group chair for surgery at J&J MedTech, said in a statement.
Smaller companies, too, such as CMR Surgical and Stereotaxis, have recently gained FDA clearance for new robotic platforms and are working to launch those systems in the U.S. In December, SS Innovations International filed an FDA submission seeking authorization for its SSi Mantra robot in multiple soft tissue procedure types.
J&J said its de novo classification request is targeting an indication covering multiple procedures in general surgery within the upper abdomen, such as gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.
Ottava’s differentiated architecture, surgical instrumentation and technological capabilities are designed to address unmet needs for clinical teams across a range of procedures, including the most complex surgeries that require a multi-quadrant approach, the company said.
Stifel analyst Rick Wise noted J&J’s approach to Ottava, with integrated table motion, is unique within the surgical robotics space. The timing of the submission announcement, just days into the first-half 2026 window the company targeted, shows J&J’s confidence in Ottava’s development, Wise wrote to clients Wednesday.
“For Intuitive Surgical, this announcement highlights the well-known, well-understood fact that the US robotic market competitive environment is going to become more-crowded,” said Wise. “That said, Intuitive’s broad and deep ecosystem, multiple robots, including the highly-differentiated DV5, indicates that the company is well-positioned to address competitive challenges.”
