Yes they are
For some reason I thought US FDA was next can off the rank but actually Euro CE looks like it could be next up
This is from the October presentation
"Currently
-Validation production run underway
-Validation testing started
-Preparing TGA ARTG Application
Next few months
-Apply for CE following ARTG
-Apply for USFDA 510(k) following full validation results
us fda application for pericoach, page-22
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