"Whenever a pharma goes public, FDA approval seems like a gold standard for their products."
Not an expert in this field, but from quick google/bing searches it does look like FDA approval for drugs is a much more difficult and rigorous process than FDA clearance for devices. Lumos seems to have the latter.
It looks like to get FDA approval (which they call "clearance") for devices all you need to do is show that it's similar to an existing device in the market.
Ann: Lumos Receives US FDA Clearance for FebriDx, page-375
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