BarrelSitter,
It's a medical device. It still needs approval from the FDA. Because it is new it will be Class 3 and take 18 months to be approved. The device will need a number of trial sites covering different populations, each one will need a lead investigator. The asx has many successful medical device companies and they all need to go through this. see eg RHY
https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
May, page-20
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