SS Innovations Submits Additional Data for FDA Review of Surgical Robotic System

09:09 AM EDT, 10/13/2026 (MT Newswires) -- SS Innovations International (SSII) said Tuesday it submitted additional information to the US Food and Drug Administration as part of the agency's review of its SSi Mantra surgical robotic system. The company said the response includes final data from an expanded human clinical and human factors validation study, along with a bridging study completed in August at Hospital Internacional de Colombia in Bucaramanga, Colombia. SS Innovations said it expects the FDA to complete its review of the response and application in Q1 2027.