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Johnson & Johnson wins FDA De Novo nod for OTTAVA robotic surgery system
The FDA authorization covers multiple upper-abdominal procedures, and J&J plans a selective U.S. launch with early customers while it expands indications via a U.S. clinical trial.
Johnson & Johnson has entered the U.S. soft-tissue robotic surgery market after receiving FDA De Novo authorization for its OTTAVA robotic surgical system, a milestone for the company’s MedTech push, according to Yahoo Finance.
The approval allows OTTAVA for multiple upper-abdominal general surgery procedures, including gastric bypass, gastrectomy, cholecystectomy, gastric sleeve surgery, appendectomy, and hiatal hernia repair. J&J will commercially launch the system with select customers in the United States to focus on early customer success, while it advances the technology into additional regulatory jurisdictions and indications gradually.
OTTAVA’s table-integrated design is positioned as a differentiation point, with J&J stating the robotic arms are incorporated directly into the operating table, potentially requiring 30% to 50% less space than traditional boom- and cart-mounted systems. The article frames the key market issue as whether J&J can convert OTTAVA’s design and broader surgical portfolio into meaningful market share in a sector where Intuitive Surgical already has an installed base and is expanding its da Vinci 5 platform.
Yahoo Finance also notes that J&J has an ongoing U.S. clinical trial for OTTAVA in inguinal hernia procedures, and that a selective rollout is intended to account for practical requirements beyond FDA authorization, including surgeon and staff training and sufficient procedure volumes to support the investment.