On Dec 6, 2007 8:31 AM, Hammers, Alexander
<[log in to unmask]> wrote:
> You raise a very interesting point, namely approval. I wasn't aware of
> ANY neuroimaging software being FDA approved and have some difficulty
> with the concept.
Information on the FDA approval process is available on their website
http://www.fda.gov/cdrh/comp/guidance/938.html
Basically anything that has something to do with clinical care for
patients and clinical decision making has to be FDA approved unless it
is being used under research protocol.
> Presumably some kind of validation is necessary - but
> how would you do that, with innumerable actual or potential
> applications? Without standard operating procedures in addition, I am
> sure any user could come up with a protocol that does not do what is
> expected, and the documentation needs seem prohibitive to me. I can see
> that e.g. stethoscopes are FDA-approved - but if you haven't been
> trained, you could not realise yours is broken, or come to completely
> wrong conclusions, even with the best stethoscope in the world.
There are a few packages for fmri acquisition that have FDA approval:
InVivo Eloquence
http://www.igc.com/Invivo/Products/fMRI/Eloquence.aspx
Neurgnostics fDAD
http://www.neurognostics.com/content/view/237/282/
... to name the first two at hand.
Woo-Suk, Tae, why do you think you need it?
Thanks,
Mikolaj
--
****************************************
Mikolaj A. Pawlak, MD PhD
Neuroradiology Research Division
Department of Radiology
University of Pennsylvania
3600 Market Street Suite 370
Philadelphia, PA 19104
Phone: 215-662-3688
Fax: 215-615-3681
mail: [log in to unmask]
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