"Hi Melissa, I wanted to get the name of the physicist who has the machine at
the Mayo so you would have it, I don't know her but Gene has talked to her
half a dozen times. I'll find out and emait it to you.
The fact is that she contacted us and asked to borrow a machine to help a
child she was seeing and before she would use it on him, she asked
permission to safety test it for us, which she did. After she saw the
results on the adrenals, she asked if she could participate in a study in
the future and, of course, we said yes.
In order to test a device like the VIBE on a person you have to go through an IRB (Investigatonal Research Board) through the FDA. We are currently working with the FDA on our compliance and approval; after we get a clearance letter we can apply for an IDE
(Ivestigational Device Exeption) for use in either this, or another FDA approved, clinical study.
In the next 6 months to 2 years our goal is to be rated as a class 2 medical device and people will be using it regularly (like an MRI, PETscan, etc)."
When I get the name of the Mayo physicist, I'll pass it on. My work here is done. ;) ;)
xxoo
Melissa
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