- SS Innovations (SSII, Financial) plans to submit a De Novo Classification Request to the FDA for its SSi Mantra 3 surgical robotic system in July 2025.
- The SSi Mantra 3 has been installed in 37 locations and has successfully completed over 750 procedures without any device-related complications.
- The system is already approved in six countries, with EU CE Mark approval in progress.
SS Innovations International, Inc. (NASDAQ: SSII), a leader in innovative surgical robotic technologies, has announced its plans to submit a De Novo Classification Request to the U.S. Food and Drug Administration (FDA) for its SSi Mantra 3 surgical robotic system in July 2025. If approved, this submission could pave the way for the system's entry into the U.S. market, expanding its global presence.
Since its launch in June 2024, the SSi Mantra 3 has seen 37 installations and has been utilized in over 750 surgical procedures, including 70 cardiac surgeries, all without device-related complications. This demonstrates a robust safety profile, bolstered further by validation from a leading contract research organization (CRO).
The upcoming FDA submission will include applications across multiple specialties, including urology, gynecology, general surgery, as well as thoracic and cardiac surgeries. This multispecialty approach positions the SSi Mantra 3 as a comprehensive surgical platform, especially significant given the complexity of cardiac procedures in robotic surgery.
Currently, the SSi Mantra system is approved in six countries, and the company is actively seeking EU CE Mark approval. This strategic move aligns with SS Innovations' mission to provide accessible and affordable robotic surgical solutions worldwide, leveraging its cost-effective technology to appeal to healthcare providers mindful of equipment costs and operational expenses.
