Lots of fluff in that press release looking to see actual Q numbers from all these reports of increased revenue and cost cutting measures. What could the FDA "question" on the 501K be? It doesn't look like a trivial issue to me, but it was presented like a "Oh, and by the way" side note in the press release. Did they file something incorrectly or incomplete? Usually these mistakes are caught quickly after the submission. No details were given on the problem(s) or a timeframe to get to a resolution. This product is already cleared in Europe, how big of an issue could this be? So- What is up at the screwball FDA should be the real question.
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