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Definitely Interesting! Especially as the cited scientific papers tell us the principle is possible. But I wonder: has the manufacturer classified this as a medical device in the FDA sense?

Was it developed and tested like so? Question to the OP.

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Yes, the device has been tested as a medical device and we will soon post certificates on the website.

My bad. I asked two questions. Thanks for answering the second one. Raises already some confidence. But could you answer the first (and more important one)? The website is silent on this topic. Would be cool. Wish you all the best for your product launch.

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

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