Monday, December 28, 2009 10:18:42 AM
FDA asks for more images, I assume they were thinking ok if they are wanting to use this thing for heart surgery then we need to see clearer images. Dean sent those images. Fda must have agreed the images were good for "something" otherwise they would have said something before asking them to narrow the labeling.
secondly, Dean said that based on his past four approvals, the "no news" from FDA is good news because they always took the 30 days or more before issuing the letter.
Lastly, it is not up to the FDA to say hey-this thing ain't up to snuff but rather "is it safe" or not. If it cannot produce clear images then I don't have to buy it. That is not the FDAs' call. Dean said he already has buyers lined up so I do not think Images are the issue here.
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