The shocking thing about the Theranos debacle is that CMS can swing such a huge hammer based on what amounts to a non-efficacy determination
Except that's not actually what it is, it's how it's being sold. CMS doesn't to my knowledge have the authority to determine efficacy.
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The findings were basically based on procedural and personnel rules. That can certainly be taken in combination to arrive at that conclusion
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But this definitely adds another dimension to medical device space that I hadn't much considered before.
End of conversation
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