SS Innovations International Inc. has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its SSi Mantra surgical robotic system. The submission covers multiple indications, including general, urological, colorectal, gynecological, and cardiac surgeries. The FDA typically aims to complete reviews of 510(k) submissions within 90 days, though the process may take longer depending on various factors. The company is also pursuing CE marking certification in the European Union, expected in the first half of 2026. No grant funding involving multiple organizations was mentioned.
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