StoryRegulatory
Johnson & Johnson receives FDA de novo authorization for Ottava robotic surgical system
Johnson & JohnsonOttava Robotic Surgical System
Johnson & Johnson MedTech received FDA de novo authorization for the Ottava robotic surgical system, a table-integrated soft tissue robot. The system is approved for 10 general surgery procedures including gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, hiatal hernia repair, fundoplication, and lysis of adhesions. Ottava is the world's first robotic surgical system with arms integrated into the operating table, reducing OR footprint by 30-50% compared to traditional cart-mounted systems.