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by notamoletracker 1835 days ago
sorry, I didn't understand your first question. we have been certified as a medical device, but we do not plan to enter the market of doctors. we originally developed NOTA as a device for home diagnostics of moles. However, when we wanted to get the 510k FDA certificate, we were told that they would test the device as a medical device, because there was already a precedent in 2018. if I still haven't answered your first question, please clarify