J&J’s Ottava Surgical Robot Set for Clinical Trial After FDA Clearance

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Advancing Robotic Surgery Innovation

Johnson & Johnson (J&J) has received FDA Investigational Device Exemption (IDE) approval to initiate U.S. clinical trials for its Ottava surgical robot. This milestone positions Ottava as a potential competitor to Intuitive Surgical’s da Vinci system, which dominates the robotic-assisted surgery market.

Key Features of the Ottava Platform

  • Integrated Arms: Ottava’s four robotic arms are built directly into the operating table, offering a compact footprint and seamless intraoperative repositioning.
  • Ethicon Instruments: Leverages exclusive J&J Ethicon surgical tools for consistency between robotic and laparoscopic procedures.
  • Polyphonic System: A digital ecosystem that integrates surgical technologies, robotics, and software to provide data-driven clinical insights.

Preparing for Clinical Trials

J&J is now setting up U.S. trial sites, enrolling patients, and training investigators. These trials represent a significant step in validating Ottava’s potential to address “unmet needs” in robotic surgery and foster competition in this rapidly growing field.

Competitive Landscape

Ottava enters a market long dominated by Intuitive Surgical’s da Vinci system. Competitors like Medtronic’s Hugo and other emerging platforms are also vying for market share in soft tissue robotic surgery, a sector with high growth potential.

Innovative Design Benefits

Ottava’s architecture enables hybrid procedures, combining robotic, laparoscopic, and open surgery modalities. Its integrated system is designed to improve workflow efficiency and surgeon experience, addressing key gaps in existing robotic platforms.

J&J’s Vision for Robotic Surgery

Hani Abouhalka, J&J’s Group Chairman of Surgery, stated: “We are bringing the best of J&J MedTech’s surgery expertise to the [Ottava] system, taking a holistic view of the science of surgery to enable new experiences across all surgical modalities.”

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