SS Innovations International, Inc. announced on May 8, 2025, its plan to submit a De Novo Classification Request to the U.S. Food and Drug Administration (FDA) for the SSi Mantra 3 surgical robotic system in July 2025. If approved, this would clear the SSi Mantra 3 for marketing in the United States.
The planned submission will include an application for multispecialty indications, covering urology, gynecology, general surgery, and thoracic and cardiac surgery. Clinical data, validated by a leading contract research organization, supports the system's ability to safely perform a wide variety of procedures.
Since sales began in August 2022, SS Innovations has installed 80 SSi Mantra systems in 75 hospitals, performing over 3,800 surgeries, including more than 200 robotic cardiac surgeries. The SSi Mantra 3, launched in June 2024, has already seen 37 installations and over 750 multispecialty procedures, including 70 cardiac cases, with no reported device-related complications.
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