OTTAVA robotic surgical system
De Novo request filed with the FDA on January 7, 2026 for upper-abdominal general surgery; FDA decision not yet reported.
What it is
J&J's own surgical robot. The FDA request covers gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair, based on an Investigational Device Exemption study. A second study in inguinal hernia was approved in late 2025.
Why it matters to the stock. It would give J&J its own soft-tissue robotic platform, and the MedTech segment needs new growth beyond its current franchises.
News
FDA grants De Novo authorization to J&J's OTTAVA surgical robot
The FDA granted De Novo marketing authorization to the OTTAVA Robotic Surgical System for upper-abdominal general surgery, including gastric bypass, gastrectomy, gallbladder removal, gastric sleeve and hiatal hernia repair.
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.