SS Innovations Submits Response to FDA for Surgical Robotic System

By Ahmed Jamerson • Tuesday, October 13 13:00 • Permanent Link

SS Innovations said it submitted its response on Oct. 5 to the FDA’s request for additional information tied to the company’s 510(k) filing for the SSI Mantra surgical robotic system.

The response included final data from an expanded human clinical and human factors validation study, along with final data from a bridging study completed in August 2026 at Hospital Internacional de Colombia in Bucaramanga, Colombia.

The company said the studies were designed to support the FDA’s review of safety, efficacy and feasibility for the system. The 510(k) submission covers the initial indication of cholecystectomy, or gallbladder removal.

SS Innovations said it expects the FDA to finish reviewing the response and the broader 510(k) filing in the first quarter of 2027.

Chairman and CEO Sudhir Srivastava said the company’s response “brings us closer” to introducing the SSI Mantra in the U.S. market. Today the company's shares have moved -3.59% to a price of $2.55. For more information, read the company's full 8-K submission here.

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