SS Innovations announced plans to submit a de novo request to the FDA for its SSi Mantra 3 robotic surgical system this July. The submission will seek approval for a broad range of specialties, including urology, gynecology, general surgery, thoracic, and cardiac procedures.
The SSi Mantra 3 system features a modular, open-console design with 3D visualization and integrated machine learning for improved safety and workflow efficiency. Launched in June 2024, it has already been used in over 750 multispecialty procedures—including 70 cardiac surgeries—across 37 installations, with no device-related complications reported.
Since entering the market in 2022, SS Innovations has installed 80 robotic systems in 75 hospitals and supported over 3,800 surgeries. Backed by real-world clinical data and validation from a leading CRO, the system is currently approved in six countries.
The company is also pursuing CE Mark approval in parallel to its FDA submission, aiming to expand its global footprint.
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