SS Innovations Submits Response to FDA Request
SS Innovations International, Inc. has announced that, on October 5, 2026, the Company submitted its response to a request for additional information letter (the “AINN”) received from the United States Food and Drug Administration (the “FDA”) with regard to the Company’s 510(k) submission for its SSi Mantra surgical robotic system (the “SSi Mantra”).
The Company’s response to the AINN includes final data from an expanded human clinical and human factors validation study (the “Study”) for the SSi Mantra. The completion of the Study was designed to provide essential evidence that the SSi Mantra meets the FDA’s requirements for safety, efficacy and feasibility, and is an important part of the Company’s 510(k) premarket notification.
The Company’s response to the AINN also includes final data from a bridging study (the “Bridging Study”), which the Company completed in August 2026 at Hospital Internacional de Colombia, a member of the Mayo Clinic Care Network located in Bucaramanga, Colombia.
The Company anticipates that the FDA will complete its review of the Company’s AINN response and the Company’s 510(k) submission for the SSi Mantra in the first quarter of 2027.
The Company engaged Daniel & Daniel Consulting, LLC to assist with the AINN response, the Study, the Bridging Study, and the 510(k) submission, which covers the initial indication of cholecystectomy (gallbladder removal).
Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “In response to the FDA’s request for additional information, we completed an expanded human clinical and human factors validation study for our SSi Mantra surgical robotic system. Our response to the FDA’s AINN brings us closer to our goal of introducing our advanced, cost-efficient SSi Mantra surgical robotic system to the U.S. market.”
Source: SS Innovations