I'm a bit sceptical as to why they are not selling ship loads of...

I'm a bit sceptical as to why they are not selling ship loads of the FebriDx devices in the existing medical markets they already have clearance for, though? Don't get me wrong, it is a great initiative, though if it truly does what they say it does then I'm sure you'll see stiff lobbying from drug manufactures of antibiotics as the size of their addressable market is about to be drastically reduced with over subscriptions being a thing of the past.

Also, there's an interesting scholar article in the National Library of Medicine that indicates of the 173 appeals lodged between 2003 to 2014 only 23 (13%) were successful. Though, I do note the study was for drugs and not medical devices. There could still be a bit of pain yet to come for shareholders unfortunately...

https://pubmed.ncbi.nlm.nih.gov/30231744/