Johnson & JohnsonFDA De Novo authorization for OTTAVA marks J&J's entry into soft-tissue robotic surgery, a key product milestone.
Johnson & Johnson has received FDA De Novo authorization for its OTTAVA robotic surgical system, marking its official entry into the U.S. soft-tissue robotic surgery market. The system features a table-integrated design that occupies 30% to 50% less space than traditional systems, and is authorized for multiple upper-abdominal general surgery procedures including gastric bypass, gastrectomy, cholecystectomy, gastric sleeve surgery, appendectomy, and hiatal hernia repair. Johnson & Johnson will begin a selective commercial launch with select U.S. customers, while also advancing the technology into additional regulatory jurisdictions and indications, with an ongoing clinical trial for inguinal hernia procedures. The company enters a market dominated by Intuitive Surgical, which had an installed base of 11,710 da Vinci systems at the end of the second quarter of 2026 and reported $2.89 billion in revenue for the quarter, up 19% year-over-year.
Johnson & JohnsonFDA De Novo authorization for OTTAVA marks J&J's entry into soft-tissue robotic surgery, a key product milestone.
Intuitive Surgical IncJ&J's FDA-approved OTTAVA enters Intuitive's dominant soft-tissue robotic surgery market, posing a competitive threat.
Microbot Medical Inc