The respiratory monitoring device maker has been one of the few companies to gain from the pandemic. As the awareness of respiratory illnesses has increased it has signed multiple distribution deals.
While it already has CE and TGA approval (the European and Australian regulatory bodies respectively) it views FDA approval as a significant next step.
The company made a 510(k) regulatory submission earlier this year and expects to receive it by the end of November.
end of november ?
up date tomorrow
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