SS Innovations International, Inc. announced that it has filed a pre-submission application with the U.S. Food and Drug Administration (FDA) requesting feedback on its SSi Mantra? Surgical Robotic System. SS Innovations received acknowledgement of this pre submission filing (#Q240119) from the Center for Devices and Radiological Health (CDRH) on January 17, 2024.

The CDRH is responsible for regulating firms who manufacture, repackage, relabel, or import medical devices sold in the United States. In addition, CDRH regulates medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems and ultrasound equipment. The SSi Mantra?

Surgical Robotic System is the first surgical system to be made in India, and one of the only systems in the world to be distinctly cost-effective with broad-spectrum surgical applications, including cardiac surgery.