FDA Authorizes First Covid Breath Testing Device

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FDA Authorizes First Covid Breath Testing Device
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The FDA issued an emergency use authorization Thursday for InspectIR Systems' 'Covid-19 breathalyzer,' the first government-approved device capable of detecting coronavirus infections in patients' breath.

Thursday for InspectIR Systems’ “Covid-19 breathalyzer,” the first government-approved device capable of detecting coronavirus infections in patients’ breath.The breathalyzer correctly identified positive samples 91.2% of the time in a study of 2,409 people, and it also performed well in a subsequent study assessing its effectiveness against the virus’ omicron variant, according to an FDA release

The breath test provides results in under three minutes, and can be administered at either healthcare facilities or mobile testing sites using an instrument roughly the size of an item of carry-on luggage, the agency said. InspectIR projects it will eventually be able to produce about 100 Covid-19 breathalyzers per week, each of which could perform about 160 tests per day, the FDA said.

At InspectIR’s current levels of production, the Covid-19 breathalyzer should boost the U.S.’s testing capacity by about 64,000 samples each month, the agency said.InspectIR’s breathalyzer detects compounds associated with Covid-19 infection using gas chromatography-mass spectrometry, a technique for analyzing chemicals that is used in everything from monitoring for

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