FDA scientists oppose the use of the 510-K process for radiation emitting devices, saying the devices needed to undergo actual testing to prove their safety. "Central to the scientists complaints is an FDA pathway to approval that allows speedy clearance if a device appears comparable to others already on the market". I wouldn't doubt for a second that the DViS is already under a PMA process. Dean, am I right?
"At ISSUE are CT scanners, MRI machines AND ANY OTHER MEDICAL DEVICE THAT USE RADIATION TO DETECT or treat diseases". Next thing we will hear from Dean is that the FDA wants beta testing. Without high quality images this becomes a catch 22.
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