FDA grants EUA for breathalyzer that detects COVID-19

A person provides a breath sample to the InspectIR COVID-19 Breathalyzer through a disposable, sanitary straw placed in the side of the machine. [Image courtesy of InspectIR]The FDA has authorized the first COVID-19 diagnostic test that detects chemicals associated with an infection in a person’s breath.

The company’s maker InspectIR (Frisco, Texas) expects to manufacture roughly 100 instruments per week, the FDA said in an announcement posted yesterday. The devices can each evaluate roughly 160 samples per day. Someone taking the test — under supervision at a doctor’s office, hospital or testing site — can receive a result in less than three minutes.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to support the development of novel COVID-19 tests with the goal of advancin…

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