FDA De Novo approval date for Painchek's Dementia App, page-3

Yes RAP's process was not smooth at all due to differences in clinical trial results etcetc.


PCK has specified by later/end of 2020 for the FDA approval, and this depends on when the application is submitted. So you should just run with that timeline as they have outlined in the company announcements.


Here is what a de novo process may look like for a device submitted to FDA which succeeds. 6 Months.
This is probably the most optimal time, so I would also expect longer just to be conservative.

LBT : ASX
21 December 2018, Submitted de novo application for FDA approval



20 May 2019, Approval confirmed.