The Food and Drug Administration has issued an emergency use authorization for what it says is the first device that can detect COVID-19 in breath samples
FILE - A sign for the Food and Drug Administration is seen in Silver Spring, Md., on Thursday, Dec. 10, 2020. On Wednesday, March 30, 2022, federal health advisers narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrig’s disease, a potential setback for patient groups who lobbied for the medication’s approval.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.” The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.
“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”
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