SS Innovations revealed that the company is planning 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.

Since sales of the system began in August 2022, the company has installed 80 SSi Mantra robotic surgical systems in 75 hospitals with over 3,800 surgeries performed, including over 200 robotic cardiac surgeries. SSi Mantra 3 launched in June 2024 and the company has installed 37 systems that have been used to perform over 750 multispeciality robotic surgical procedures, including 70 cardiac cases.

SS Innovations said real-world clinical data supported by a contract research organization (CRO) supports SSi Mantra 3’s ability to safely perform a variety of surgical procedures. The planned submission will include an application for multispecialty indications including urology, gynecology, general surgery, and thoracic and cardiac surgery.

“We currently have approval to market our SSi Mantra surgical robotic system in six countries and continue to advance our global expansion,” said SS Innovations chairman and CEO Dr. Sudhir Srivastava. “We are taking important steps, including the planned De Novo application to the FDA, to introduce our empowering, cost-effective surgical robotic technology to the U.S. market. In parallel, we are pursuing European Union CE Mark approval for our SSi Mantra surgical robotic system and look forward to our future with great confidence.”

Last month, the company successfully performed India’s first north-to-south robotic cardiac telesurgery, bridging a 2,000-kilometer distance between the company’s headquarters in Gurugram, New Delhi, and the Aster CMI Hospital in Bengaluru.