regulatory
confidence high
sentiment neutral
materiality 0.50
SS Innovations submits FDA response on SSi Mantra 510(k); decision expected Q1 2027
SS Innovations International, Inc.
- SSi submitted its response to the FDA's request for additional information (AINN) on October 5, 2026, regarding the 510(k) for its SSi Mantra surgical robotic system.
- Response includes final data from an expanded human clinical and human factors validation study plus a bridging study completed in August 2026 at Hospital Internacional de Colombia in Bucaramanga.
- SSi expects the FDA to complete review of the AINN response and the 510(k) in Q1 2027; the submission covers the initial indication of cholecystectomy (gallbladder removal).
- The company engaged Daniel & Daniel Consulting, LLC to assist with the AINN response, the validation study, the bridging study and the 510(k).
- CEO Sudhir Srivastava said the response brings SSi closer to U.S. market entry; the SSi Mantra has been clinically validated in India across more than 190 surgical procedure types.