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SS Innovations submits FDA response for SSi Mantra, expects review completion in Q1 2027
SSIISS Innovations International, Inc.
SS Innovations International submitted its response to a request for additional information from the U.S. Food and Drug Administration regarding its 510(k) application for the SSi Mantra surgical robotic system on October 5, 2026. The submission includes final data from an expanded human clinical study and a bridging study conducted in Colombia. The company anticipates the FDA will complete its review of the 510(k) submission in the first quarter of 2027. SS Innovations International develops innovative surgical robotic technologies to make robotic surgery affordable and accessible globally.