It's a big chunk of mine as well !
At the AGM I asked the question about progress on CONNEQT Pulse clearance and Ahmed Qasem ( CSO ) took the lead in answering my question.
In essence ( I'm paraphrasing ), Ahmed said all the testing of the Pulse device had shown, beyond doubt, that it met the "equivalence" criteria to achieve FDA Clearance and he was extremely confident we would achieve clearance.
The FDA process takes time, sometimes odd issues crop up with the FDA "ie. is the display clear on the CONNEQT Pulse for vision impaired - my wild example btw" , but nothing that is a show stopper - more about dotting the i's and crossing the ts.
IMO
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