TechMediaBreaks – SS Innovations International, Inc. (NASDAQ: SSII) Submits FDA Response for SSi Mantra Surgical Robotic System
SS Innovations International (NASDAQ: SSII) , a developer of surgical robotic technologies, announced that it submitted its response to a request for additional information from the U.S. Food and Drug Administration (FDA) on Oct. 5, 2026, regarding its 510(k) submission for the SSi Mantra surgical robotic system. The response includes final data from an expanded human clinical and human factors validation study, as well as a bridging study completed in August 2026 at Hospital Internacional de Colombia, a member of the Mayo Clinic Care Network. The submission covers the initial indication of cholecystectomy, or gallbladder removal. The company anticipates that…