Ann: CardieX Submits FDA Application for CONNEQT Pulse, page-25

In the MST financial interview Craig starts talking about the Pulse at around 13.30 min mark.
AT 14.15 min he states that initial FDA comments is expected around or within 30 days and if there are no major questions production will start.
Commercial launch expected late November 2022
Once FDA clearance is in place they can have more serious conversations with there pre launch partners Bayer and others they are talking to. Craig mentioned he wants these in place before the launch.
I am no expert but i feel that there should not be any problems with the FDA submission as Craig mentioned they have done it before.