SSi Mantra surgical robotic system submits for FDA approval

SS Innovations International, Inc, India’s home grown surgical robotics pioneer, has announced a landmark milestone with the submission of its 510(k) premarket notification to the US Food and Drug Administration (FDA) for the company’s next-generation SSi Mantra surgical robotic system.

The submission, completed on December 5, 2025, covers multiple high demand surgical specialties including general, urological, colorectal, gynaecological, and cardiac procedures.

The move marks one of the most significant global regulatory steps ever undertaken by an Indian developed surgical robotic platform, positioning India prominently in a sector long dominated by international players.