SS Innovations Submits Response to FDA for SSI Mantra Robotic System

By Tamara Parker • Tuesday, October 13 16:00 • Permanent Link

SS Innovations International said it submitted its response on Oct. 5 to an FDA request for additional information tied to its 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 expanded study was designed to support safety, efficacy and feasibility requirements for the SSI Mantra, while the bridging study was part of the 510(k) premarket notification package. The filing covers an initial indication for cholecystectomy, or gallbladder removal.

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

Chief Executive Sudhir Srivastava said the company completed the expanded validation study in response to the FDA’s request and said the submission moves the company closer to introducing the SSI Mantra in the U.S. market. The market has reacted to these announcements by moving the company's shares -3.59% to a price of $2.55. For the full picture, make sure to review SS Innovations International's 8-K report.

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