SS Innovations plans FDA De Novo submission for SSi Mantra 3 in July 2025

SS Innovations International, Inc.

Planned De Novo Classification Request to FDA in July 2025 for multispecialty indications including urology, gynecology, general surgery, thoracic and cardiac.
80 SSi Mantra systems installed in 75 hospitals since August 2022; over 3,800 surgeries performed, including 200 robotic cardiac.
SSi Mantra 3 launched June 2024; 37 systems installed with over 750 procedures (70 cardiac) and no device-related mortality or complications.
Clinical data validated by a leading third-party CRO for safety, feasibility and efficacy.
Company holds approvals in seven countries and is also pursuing European CE Mark approval.

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