FDA De Novo approval date for Painchek's Dementia App

Hi All,

When do we all anticipate Painchek to receive FDA regulatory approval for their adult App?

According to Painchek's ANNs, they have completed the de-novo FDA pre-submission documentation and expected to have the documentation submitted in late Jan/early Feb 2019. Since then they have had a teleconference call (April 2019) where they submitted more data and had scheduled a face to face meeting with the FDA prior to June 30.

I have 'cross referenced' Painchek's process with that of ResApp who are seeking FDA approval and have followed the same de novo regulatory pathway. In their case they filed pre-submission documentation with the FDA on 31 Dec 2015, had a pre-submission meeting with the FDA on 14 Mar 2016 which confirmed the de novo regulatory pathway. on 15 April 2019 they submitted the de novo submission documentation.

I have not been able to find any details on either ResApp or Painchek on the FDA website/register.

Has anyone else had any luck? And when do we think Painchek will gain FDA clearance. It seems to have taken ResApp nearly 3.5 years and counting.

Appreciate any info, estimates and reasoning.

Cheers