Dear Dr. Hammers, Alexander and other replied persons
I have used Analyze software (Mayo Clinic) for epilepsy patients during last 10 years.
It have been provided the functions of SISCOM, invasive electoro-grid mapping on patients' brain MRI,
multimodal image integration for epilepsy surgery, and Analyze have been very successful for clinical purposes.
But recently the Korean ministry of health and welfare prohibited the clinical uses of Analyze,
because Analyze was not approved by FDA.
So, We need another software package with FDA approved software such as Analyze for clinical uses.
Best regards.
Woo Suk, Tae Ph.D
Seoul, Korea
-----Original Message-----
From: Hammers, Alexander [mailto:[log in to unmask]]
Sent: Thursday, December 06, 2007 10:32 PM
To: Woo-Suk, Tae; [log in to unmask]
Subject: RE: [SPM] FDA approved neuroimaging software: Is there any?
Dear Tae,
I can recommend Analyze for what it does (I've mainly used the ROI tool
and rendering, as well as some image algebra, morphological operations,
played with SISCOM once, etc.) - it does that very well. However, as you
probably know, it is so expensive that that is a prohibitive factor for
many centres.
Also, while I've successfully used it with Nifti, others have had
problems.
For image registration and tissue class segmentation, I use SPM5 or
Exbrain and have never compared them to what Analyze does.
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. 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.
So, the question is, _is_ there _any_ FDA-(or other agency)-approved
neuroimaging software, and if so, where can one get hold of such a list
and the criteria for approval? And if there is such a list, in what way
would it be useful to you?
(I have found one document relating to CURRY
(http://www.fda.gov/cdrh/pdf/k001781.pdf) where the argumentation (if I
understand correctly) is essentially that it intends to do similar
things to something marketed before 1976 when some Act came into force
and therefore it's ok to market - not what any scientist would regard as
validation I'm sure!). If that's the standard, I think you risk paying
for a marketing strategy which will not, per se, give you any additional
advantage over open source tools.
I'm very curious and looking forward to hearing more,
Alexander
-----Original Message-----
From: SPM (Statistical Parametric Mapping) [mailto:[log in to unmask]]
On Behalf Of Woo-Suk, Tae
Sent: 06 December 2007 07:41
To: [log in to unmask]
Subject: [SPM] FDA approved neuroimaging software
Dear SPM community lists.
Who can recommend FDA approved neuroimaging software such as Analyze
(BIR, Mayo clinic) to me?
The functions of image registration, segmentation, image algebra,
multi-objects 3D visualization are needed.
Woo Suk, Tae Ph.D.
Seoul, Korea
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