Quote:
Originally Posted by john1947
I wonder why this wonderful device has not been approved in the USA .
It is avalable now in Canada and many other countries.
Thanks
john
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I believe that the US trials are close to completion. The research teams had asked for several extensions. I know for a fact that there have been several issues, such as insertion site infections and tube displacements. I doubt this will ever become a mainstay product. There are other drugs and devices currently being tested that appear to be simpler, safer, and better.
Nevertheless, this is another example of the time delay in the US for getting drugs/products approved. Remember, DatScan received European approval almost 10 years prior to US approval.