FDA approves first breathalyzer that detects COVID-19


WASHINGTON — The Food and Drug Administration on Thursday granted an emergency use authorization for the first device that can detect COVID-19 in breath samples.

According to the FDA, the InspectIR COVID-19 Breathalyzer is about the size of a piece of hand luggage and can be used in doctor’s offices, hospitals and mobile test centers. The test, which can provide results in less than three minutes, must be administered under the supervision of a licensed healthcare provider.

dr Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “another example of the rapid innovation occurring in diagnostic tests for COVID-19.”

The FDA said the device was 91.2% accurate in identifying positive test samples and 99.3% accurate in identifying negative test samples.

“InspectIR expects to be able to produce approximately 100 instruments per week, each of which can be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity with the InspectIR COVID-19 breathalyzer is expected to increase by approximately 64,000 samples per month.” FDA approves first breathalyzer that detects COVID-19


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