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.
Business · 8 sources · Jul 22, 2026Read itThe journal
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About Da Vinci Surgical System
The da Vinci Surgical System is a robotic surgical platform that uses a minimally invasive surgical approach and is manufactured by Intuitive Surgical. The system is used for surgical procedures including prostatectomies, cardiac valve repair and renal and gynecologic interventions.
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