The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.
The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor’s offices, hospitals and mobile testing sites. The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed 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.”
The U.S. Environmental Protection Agency ordered Norfolk Southern on Tuesday to pay for the cleanup of the East Palestine, Ohio train wreck and chemical release.
Environmental Protection Agency Head Michael Regan made a stop in East Palestine, Ohio, to speak with residents who continue to raise concerns about the health and safety of their town.
A new study predicts that rising energy costs that have followed in the wake of Russia's war with Ukraine could push millions of people around the globe into extreme poverty.
One people killed in a shooting in El Paso, Ohio residents are worried about health issues after a serious train derailment, and there has been a decrease in overdose deaths in the U.S. Here is everything you Need2Know for Thursday, February 16, 2023.
