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SS Innovations Responds to FDA Request for SSi Mantra Surgical System

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SSII$2.47 −3.14%

SS Innovations International, Inc. (NASDAQ:SSII) submitted its response to a request for additional information from the U.S. Food and Drug Administration regarding its 510(k) premarket notification for the SSi Mantra surgical robotic system. The company filed the response on October 5, 2026, after completing an expanded human clinical and human factors validation study. It also included final data from an August 2026 bridging study conducted at Hospital Internacional de Colombia.

The submission covers the initial application for gallbladder removal procedures, known as cholecystectomy. The additional data aims to prove that the modular, multi-arm surgical robot meets federal standards for safety, efficacy, and operational feasibility. Bringing the SSi Mantra through regulatory review is a key step toward making the technology commercially available in the United States.

The company expects the regulator to complete its review of the additional submission and overall application during the first quarter of 2027. Shares of the company were trading at $2.55, down 3.59% following the announcement.

Key points

  • SS Innovations submitted additional clinical and validation study data to the FDA on October 5, 2026, for its SSi Mantra robotic system.
  • The filing includes results from a bridging study completed in Colombia in August 2026.
  • The 510(k) premarket notification covers an initial indication for gallbladder removal surgery.
  • The company expects the FDA to finish reviewing the application in the first quarter of 2027.

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Questions and answers

What did SS Innovations submit to the FDA?

SS Innovations submitted a response to the FDA request for additional information, including final data from an expanded human clinical study and a bridging study for its SSi Mantra surgical robotic system.

When does SS Innovations expect FDA review completion for the SSi Mantra?

The company anticipates that the FDA will finish reviewing its submission and additional information response in the first quarter of 2027.

What medical procedure is covered in the SSi Mantra FDA submission?

The 510(k) premarket submission covers an initial indication for gallbladder removal, also known as cholecystectomy.