Edit for clarity.
Ellume experience the blunt end of FDA Headwinds on their OTC test back in20192016.
FDA Device Panel Findings Summary
They have addressed the issues (with the help of a bit of nano glue) and are concurrently progressing commercialisation and Patent Coverage - the WIPO National Phase Regional applications point to their focus and regions they'll market to outside of USA too.
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Edit for clarity.Ellume experience the blunt end of FDA...
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