FDA De Novo approval date for Painchek's Dementia App, page-2

You shouldn't use ResApp as a yardstick here. They failed in their US trial miserably thereby knocking their reputation to kingdom high. Any regulatory body would be extra careful with their claim after that. Even their CE Mark application seems to take forever while ours just came out of thin air.

But having said all that, your enquiry is the million dollar question here. FDA is the holy grail of all approval. I understand that the requirements are complex and complicated. We just have to be patient. It won't be easy but well worth it once it is obtained. And FYI, the management seems to expect approval by early 2020.