Not too much relevance as RAP is a non invasive diagnostic tool. It is a Class 2 medical device. It satisfies safety. It just has to satisfy efficacy.
It is expected that efficacy will be about an 80% accuracy rate which is the same level as the local doctor. We are already at 95% and above.
Interesting read., page-5
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
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