External Email - Use Caution        

 If you have not looked at the Freesurfer license terms (which you agreed 
to when you downloaded the 
software),https://secure-web.cisco.com/1TLtJ8aYiTR8TmbT0XIgGWuiazFxBl5kXBTSkbdLnaoMDDCGrCYU0HiPG1Rd2aYMgX_f_VY2luydHczqDxUBDzhZEwbacG4qp6qwiZPMmbXKGv0Ryvn0XCAMPA5g0MxkWwHqoU8P8Nr0Db3j6uvD8lfEZ6Wkzx5F9zcQgiuIQ8Gb0vfdVMOIHvS6qDAf6k1iChKCrGUWplARGJRXJNbSBE8KAEg4wJ8hA72DWeE801Q6t_lo2Bk0SXd1hcFEsne4gPyWH_29RiHckZPfZMyAl7ayopJE98uthMmjYi2xBIkf3u0ISQSSNhaIGTp5AhARjHJc9r8MAkLSrGlQc8ViVBw/https%3A%2F%2Fgithub.com%2Ffreesurfer%2Ffreesurfer%2Fblob%2Fdev%2FLICENSE.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://secure-web.cisco.com/1q3oL4x5gqV_bdyKyRolyR9hw97oWH5oVRLzSotDPItR5GWo823uPbDV-qbLIcPZi8yiKAsU1U_3qYiRT_Va1aCW8kYvMGtM3jewxPEYAM_OWt6LJ-nf7BYt9279pXEW5w6ytY_kai534Hlz3AmWimuXTGoeTBrXfSLAHmF9u_X_s1HVaqVNZMFp3LrusDh5D07g0HMxg3IzGAXQNfjdpgMxjgAU4f6sXQ_BCAEs-woKvihQrDATyl4a3t594Z5EmrefAzESjgEm9sh1_CJAPyXgNXA73iOlV_qAB4a6m25Xtk_i1XZjaHMZTkmVmBhoYtkHO21npxrKPN1jdUtQtKQ/https%3A%2F%2Fgithub.com%2Ffreesurfer%2Ffreesurfer%2Ftree%2Fdev%2Fdistribution%2Fdocs
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://secure-web.cisco.com/18FWAuTV9mgC0-k8_UudIcvI2UfmRMWvQDPOWoIWhlHFahubpg8atM_RAWqQKKwJ08yzA_w36kGJ8m4FHU5RNHAM-eYcwFVzFmLc_mW42TSBZYePDIfW8fwmD5QbRZyVNkwcEDfhe6WSNhJs741rE9b0r5yJXlJo0GJrz7BNHBXYzf8sSQQx60m3l6s3MInYnoMGpKtIPuFU4J9xA8iMhNpkR_MD1Qpm6_05KXSO1St7ja3Eb-4Y8Suu1c1AWS2XLzfoc2NOmdLGaUfivxaT3mkLa8vx5jArDLCiTIQCvl-1wBT9MISxXwMGEzQba5Y60EJ56pJJN_jnnb8o6RaC-jw/https%3A%2F%2Fsurfer.nmr.mgh..harvard.edu%2Ffswiki%2Frel7downloads
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 <y...@micron-kobe.com> 
wrote:        External Email - Use 
Caution        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:Clinical Trial Usage:
- Has FreeSurfer been utilized in any clinical trials?
- If so, have any of these trials been submitted for regulatory approval?

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_______________________________________________Freesurfer mailing 
listfreesur...@nmr.mgh.harvard.eduhttps://mail.nmr.mgh.harvard.edu/mailman/listinfo/freesurfer

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