Fort Lauderdale, Florida-based SS Innovations plans to submit in July. The submission will include an application for multispecialty indications, including urology, gynecology, general surgery, and thoracic and cardiac surgery.
The SSI Mantra 3 system features a modular, open-console design with 3D visualization and enhanced ergonomics. Integrated machine learning models further enhance procedural safety and efficiency. Surgical robotics experts have described SS Innovations as a company to watch.
Since the company began selling its system in August 2022, it has installed 80 SSi Mantra robotic surgical systems in 75 hospitals. Over 3,800 surgeries have been performed, including over 200 robotic cardiac surgeries.
The SSi Mantra 3 version was launched in June 2024, and SS Innovations has already installed 37 systems, which have been utilized to perform more than 750 multispecialty robotic surgical procedures, including 70 cardiac cases. The company reports no device-related mortality, injury, or complications.
According to SS Innovations, real-world clinical data validated by a leading contract research organization supports the SSi Mantra 3’s ability to safely perform a wide variety of surgical procedures.
“We currently have approval to market our SSi Mantra surgical robotic system in six countries and continue to advance our global expansion,” Sudhir Srivastava, board chair and CEO of SS Innovations, said in a news release.
“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.”
