SS Innovations submits FDA response with final data from expanded SSi Mantra clinical, human factors study
Bitget2026/10/13 13:26- SS Innovations submitted its response on Oct. 5, 2026 to an FDA request tied to its SSi Mantra 510(k) filing.
- Results have already been provided to the FDA, including final data from an expanded human clinical and human-factors validation study.
- The submission also included final data from a bridging study completed in August 2026 in Colombia.
- The studies were intended to support the system’s safety and feasibility case for an initial U.S. indication in gallbladder removal.
- FDA review of the response and the 510(k) is expected to conclude in the first quarter of 2027.
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