RE:RE:Ventripoint Response to Interactive Review for Recent 510(k)I believe that VMS - VPT does have FDA attention this time. It's my understanding that on the initial application the reviewer(s) made errors in their interpretation of the test and rejected the application without review. With that announcement, Dr Adams released news of an appeal on the FDA decision. I think of FDA as being corrupt and arrogant so the business of an appeal would be undesirable to them when the test actually had passing grades. In a face saving gesture they altered the trials name and approved it, "hand delivering it to Dr Adams" when approved. So yes, I think they now have FDA "owing them one", so to speak. That said, I believe FDA will fast track this submission and it's my belief that good news will prevail sooner than later.
In my opinion