I am aware that the FDA recommends only using FDA-approved software for segmentation when making a 3D printed model intended for diagnostic purpose. I was wondering if there is an easily accessible list of such software? Or is there a place where you can double check if a software is FDA-approved (aside from looking up the software itself)?
Your question is quite ambiguous" " FDA recommends only using FDA-approved "
Are we talking about approval or recommendation?
AFAIK the FDA will never "recommend" anything when it comes to medical devices and medical software. The scope of the FDA mission in that regard is very specific.
If a software system is a medical device, or is part of a system which is a medical device, then the FDA role is to ensure it is marketed in accordance with the regulation, which can mean "approval" as well as other mechanisms.
" intended for diagnostic purpose. " is the main key point here.
Do you have an example of such a software - i.e. being distributed/labelled/marketed for this specific purpose? I haven't been able to find anything related in the various FDA Databases.
Closest "hit" is a mention of segmentation in 3D modelling of lung volume for a drug approval submission:
https://www.fda.gov/media/120480/download
Some info:
https://www.fda.gov/medical-devices/products-and-medical-procedures/3d-printing-medical-devices
https://www.researchgate.net/post/Why_is_3DSlicer_not_FDA_approved
Materialise Mimics is the big one. This article lists essentially two (https://proto3000.com/applications/application-guide-data-segmentation-for-medical-3d-printing/), basically showing Mimics and Vitrea. I've tried the export to STL function in Vitrea, but unfortunately have not gotten it to work (if others have had success with Vitrea, I'd love to hear it and figure out what I'm doing wrong with the STL export).
It had been a while since I searched the subject, but it looks like 3DSystems got one approved too - https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183489.pdf
That's all that I'm aware of, but my search was a bit out of date with not knowing the 3D Systems approval. For a long time, Materialise Mimics was the only one (or functional one for me if others have had success with Vitrea)
While there are a million (probably more like dozens) of imaging analysis software that has some type of clearance for medical image segmentation, the kicker for 3D printing segmentation is a poor or non-existent functional export to STL. Even with the FDA approval for some of these, looking at the language for some of the approvals will list specific indications like ortho, maxillofacial, and cardiac - does that infer that it is ok to use for other indications and other organs, the subject is more gray than black and white
The aforementioned software from Materialise (Mimics Innovation Suite) is probably the industry standard, but is also fairly expensive. There is a research version (not certified, cheaper) and a med. certified version of the software. The differences are, as far as I know, mainly the price and the certification (Medical is more expensive). In addition, new functions are implemented with a time delay in the med. version of the software (due to the time-consuming certification). Further med. certified segmentation programs are available from Brainlab or for example Simpleware / Synopsys. ... a DICOM viewer, which can also export STL files (with limited segmentation functions) is OsiriX MD / – this tool is also certified.
Blue sky plan software is also FDA approved. Though it is dedicated only for dental implant planning but you can do simple segmentations on this software and export as a stl file.
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