Ann: Results of CDXO and November Options Exercise Conversions, page-48

So...if I get you right @lexcorp, you are saying the cdx technology doesn't work to FDA standards.
The new Pulse device has same sensors and algorithms and got validated against their own FDA approved Spygmocor device....so there shouldn't be any issues to get FDA approval for any device with their own technology.

There might be an issue with some other features provided by Mobvoi, which aren't possible to get FDA clearance. Thats why Coops is pushing their own devices with FDA clearance and medical rebates to reach out to a more medical home monitoring market. This needs patience here...
Rome is not made in a day.