FDA authorizes 1st breath test for COVID-19 infection.

The Food and Drug Administration issued an emergency use authorization on Thursday for the first device that can detect COVID-19 in breath samples, according to the agency.

According to the FDA, the InspectIR COVID-19 Breathalyzer is roughly the size of a carry-on bag and can be utilized in doctor’s offices, hospitals, and mobile testing sites. The test, which has a turnaround time of less than three minutes, must be performed under the supervision of a registered health care provider.

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.”

According to him, the FDA is also encouraging the development of new testing capabilities. The company, which concentrates on portable opiate and cannabis detection instruments, hopes to be able to create about 100 of the devices every week, with each device capable of evaluating about 160 samples per day. According to the company’s website, the breathalyzer is the first of its kind to be commercially accessible.

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