If the device was working as it should, how could the new and "better" FDA team have arrived at the NSE decision? With everything they have requested, including radiologist reviews which supposedly contained glowing results, I no longer have any faith that they could have arrived at this decision if the DVIS functions as Dean says it does. If anyone can offer a glimmer of hope as to why FDA's decision is not a valid one, let's hear it.
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