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Tuesday, February 09, 2010 7:42:16 PM
Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.
There is BILLIONS of $ to be made in the ct xray device industry in the future...This is not far fetched but Obama is good friends with GE ceo what if obama receiving money on the side or (some people high up in the FDA or government) to have the FDA shelve the dominion or freeze all radiological devices up for approval if they don't have these new these new demands???
And GE is working to meet these requirements and just adds all these demands to their existing xray and ct devices with a simple computerized add-on display??? Which will make the Dominion just another simple eveyday Xray Decvice... A Possible conspiracy maybe. Makes sense in my head.
or...hopefully the Dominion has a low enough radition output to not even be involved in this regualtion meeting in March with the FDA. Hopefully the Domninion is approved before the meeting and is seen as a ground breaking medical device with so little radiation it doesn't need any displays or alerts for radiation doses.
or we see more delays as IMGG must wait for the new radiological device regualtions to be set and fix the Dominion. And also has to go through radiation tests with the FDA after the March 30th meeting to make sure they meet the requirements...this can take a long time.
Anyone feel me???
I am long but I have concerns! I do hope we are approved soon!
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