Da Vinci Surgical System

J&J Wins FDA De Novo OTTAVA System

Johnson & Johnson has received FDA De Novo clearance for its Ottava robotic surgical system, marking its entry into the U.S. market as a table-integrated, space-saving alternative aimed at general soft-tissue procedures. The company plans a selective U.S. rollout and ongoing global expansion, supported by an inguinal hernia trial and continued development of additional indications and regulatory approvals amid competition from Intuitive Surgical's established da Vinci platform.