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> how many medical devices are thrown out simply due to issues with the companion software

If in the US, did y'all get FDA certification for the internally developed software? Did the vendor?

https://www.fda.gov/medical-devices/device-advice-comprehens...



Not in the US, nor did the software relay anything back to the 'patient' in any way. They came in and gave permission for phenotype measurements for genetic studies.




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