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If you have not looked at the Freesurfer license terms (which you agreed to when you downloaded the software),
https://github.com/freesurfer/freesurfer/blob/dev/LICENSE.txt

- then you should note the following in Part B, section (e), number 4,

4. The Software has been designed for research purposes only and has
   not been reviewed or approved by the Food and Drug Administration
   or by any other agency. YOU ACKNOWLEDGE AND AGREE THAT CLINICAL
   APPLICATIONS ARE NEITHER RECOMMENDED NOR ADVISED. Any
   commercialization of the Software is at the sole risk of the party
   or parties engaged in such commercialization. You further agree to
   use, reproduce, make derivative works of, display and distribute
   the Software in compliance with all applicable governmental laws,
   regulations and orders, including without limitation those relating
   to export and import control.

I am not aware of any reviews by the FDA (or from other government agencies) that have approved freesurfer for clinical use.

Although the MGH license is essentially open source allowing use/re-distribution of the software, it is however subject to the license restrictions of the included 3rd party code as noted in Part B, section (e), number 3,

3. This Software License does not grant any rights with respect to
   third party software, except those rights that MGH has been
   authorized by a third party to grant to you, and accordingly you
   are solely responsible for (i) obtaining any permissions from third
   parties that you need to use, reproduce, make derivative works of,
   display and distribute the Software, and (ii) informing your
   sublicensees, including without limitation your end-users, of their
   obligations to secure any such required permissions.

Those 3rd party licenses can be found under ,
https://github.com/freesurfer/freesurfer/tree/dev/distribution/docs

Some of those licenses may stipulate that once their 3rd party code in freesurfer is used in a commercial/for profit setting, then a paid for commercial license would need to be negotiated with the copyright holder.

Freesurfer 6 is about ~7 years old now.  Freesurfer 7 releases were made available from 2020 thru 2023 with the last release as 7.4.1 in June of 2023.  Freesurfer 8.0.0 is about to be released (February 2025).   You can see the current releases here,
https://surfer.nmr.mgh.harvard.edu/fswiki/rel7downloads

It would not surprise me if there was no point now in trying to get Freesurfer 6 approved for clinical trials because it will not run on recent versions of Linux OS’s.

- R.

On Feb 19, 2025, at 04:58, Yeh Shang Ming <yeh@micron-kobe.com> wrote:

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Dear Sir/Madam,

My name is Shang-Ming (Tony) Yeh, and I work at an imaging CRO based in Japan.

We are currently using FreeSurfer version 6.0.0 and are considering its use in a potential project. To support our evaluation, we would appreciate your insights on the following:
  1. Clinical Trial Usage:
    - Has FreeSurfer been utilized in any clinical trials?
    - If so, have any of these trials been submitted for regulatory approval?

  2. Comparative Studies:
    - Are there any publications that compare FreeSurfer with other similar software?
If you have any relevant information or publications, we would greatly appreciate it if you could share them with us.

Thank you for your time and support. We look forward to your response.

Sincerely,
Shang-Ming (Tony) Yeh
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