Monogram Technologies (MGRM) said Wednesday the US Food and Drug Administration has placed its 510(k) premarket filing submission for the mBos TKA System on hold pending an additional information request on the robotic surgical system.
The company said it has 180 days from Sept. 30 to provide a complete response to the request or the FDA will consider its application withdrawn. Monogram Technologies is working on the response.
In a separate statement, Monogram said it closed its continuous offering of 8% series D cumulative preferred stock, raising about $13 million in gross proceeds to be used for general working capital.
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