thanks @Mani_here
that first video added more information about reason for FDA breakthrough recognition .
some 50% of metastatic cases need lymph nodes surgically removed and biopsy done - even if negative.
and this system evaluates beforehand with having biopsy. They have stated that biopsy is not needed previously, but I did not understand the reason why.
very significant, medically important, shortest path to market for business/shareholders
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