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orangecat

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orangecat

Re: timflos22 post# 8757

Wednesday, 05/10/2017 10:00:46 PM

Wednesday, May 10, 2017 10:00:46 PM

Post# of 27410
300 to 500. They have not publicly stated if they will go the 510k or PMA route, but the most recent timeline and trial size points to the longer PMA route. Longer is a bummer, but positive results will provide more evidence of efficacy which will significantly help marketing and adoption. Not just in the US, but worldwide.
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