November 18, 2024- Johnson & Johnson MedTech announced that the U.S. Food & Drug Administration (FDA) has approved the OTTAVA™ robotic surgical system investigational device exemption (IDE), which allows the clinical trial to begin at U.S. sites. The Company will now prepare clinical trial sites to receive OTTAVA systems, enroll patients, and begin surgical cases.
The OTTAVA System is designed to set a new standard for the modern operating room (OR) and transform the surgical experience. The system’s unique unified architecture, surgical instrumentation powered by Ethicon expertise, and Johnson & Johnson MedTech’s digital ecosystem are intended to provide versatility to meet the needs of each patient’s care and each surgeon’s clinical approach.
The OTTAVA system features four, low-profile robotic arms incorporated into the operating table that can be stowed underneath. This unified architecture allows for a compact footprint designed to support robotic, laparoscopic, hybrid, and open surgery with more working space for clinical teams.
Johnson & Johnson MedTech is building on its global portfolio of surgical technologies to advance OTTAVA and help surgical teams and hospitals provide more patients with the benefits of robotic surgery. The system is designed to address unmet needs that persist in robotic surgery today, while driving choice and competition in an underpenetrated and high-growth market.