J&J submits OTTAVA surgical robot to the FDA for upper-abdominal general surgery

Johnson & Johnson MedTech filed a De Novo request with the FDA for its OTTAVA robotic surgical system, aimed at multiple upper-abdominal general surgery procedures. The submission rests on an Investigational Device Exemption study in gastric bypass, and a second study in inguinal hernia was approved in late 2025. For traders, this is the first formal step toward a soft-tissue robot that could give the MedTech segment a new platform, although no FDA decision date was given.

• De Novo request covers gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair
• Data come from an IDE study in Roux-en-Y gastric bypass; first study cases were completed in early 2025
• A second IDE study in inguinal hernia procedures was approved in late 2025
• The company gave no FDA decision date and the system is not yet authorized for sale