Given that it has been well over 30 days since end of Q1 and we haven't heard about the IDE approval, I think it's a pretty safe assumption that it was not green lit by the FDA. They must have found it deficient in some way which means it'll be another 30 day review cycle if the company chooses to respond, assuming it wasn't an outright rejection.
IDE green light imminent? Nice bump on Nasdaq last night., page-46
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