The other thing to add is that as it does not as you rightly point out have any implications for the health of the tested individual in its manner of operation it is possible that the regulator could give conditional approval for it to be used immediately in a medical treatment setting with conditions as to supervision and reporting of its accuracy etc; in the field and then rely upon the real world testing results to grant full approval in due course.
Brainchip have two big picture propositions running on the success of this use of AKD1000 for Covid-19 detection. The first obviously is Covid-19 the second is the original reason that Professor Barry Marshall came on board which was the furthering of his already advanced research into the detection of early signs of gastric cancers on exhaled Volatile Organic Compounds.
The work that Peter van der Made presented as providing proof of concept for the ability of AKD1000 to test for Covid-19 at 94% accuracy is the same concept that will allow for the testing of VOC for gastric cancer and as a result of the research out of Flinders University neck and head cancers as well.
I personally doubt that Brainchip would be satisfied by simply producing a device which could be sold by Demtel on late night television with a free set of steak knifes this is a much more important product with implications for the whole world.
My opinion only DYOR.
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