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 FDA has approved Opvee, which can reverse fentanyl and other opioid overdoses.
Powerful Typhoon Mawar churned slowly over the U.S. Pacific territory of Guam on Thursday, lashing the island with wind and rain, tearing down trees, walls and power lines, flipping cars, and pushing dangerous storm surge ashore as first-responders waited for daylight to see the full extent of the damage.
U.S. health regulators on Monday approved a new easy-to-use version of a medication to reverse overdoses caused by fentanyl and other opioids driving the nation’s drug crisis.
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A new study shows that climate change is making it harder to fall asleep. The study, published in Cell Press over the weekend, shows that millions of people are already sleeping less because of higher overnight temperatures.
Jeff Bezos' rocket company has won a NASA contract to land astronauts on the moon, two years after it lost out to SpaceX.
The natural burst of El Nino warming that changes weather worldwide is far costlier with longer-lasting expenses than experts had thought, averaging trillions of dollars in damage, a new study found.
Drug overdose deaths in the U.S. went up slightly last year after two big leaps during the pandemic.
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