I don;t think I am bashing by any stretch. In order for DEan to get his device through appeal he will need to gather data and have a competent team present that to the FDA. They will need to explain his controls to a level that will make the FDA conclude that the risk is minimal and that DVIS should be downgraded.This will take engineers and lawyers and much money but this is our only hope...PMA is a Battan death march unless GE buys us and runs the trails. I expect a PR before or during RSNA that will announce that they have had a sit down with FDA. Let see if I am right.
News 
Market Data 
Discover 
AI
