The following is an example of FDA approved device (that's what they
call it. not sofware).
On Dec 6, 2007 8:31 AM, Hammers, Alexander
<[log in to unmask]> wrote:
> 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
> 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,
> -----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
Satrajit Ghosh, PhD
Speech Communications Group
Research Lab of Electronics @ [ M I T ]