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.”
Heavy rainfall flooded parts of Massachusetts and Rhode Island, with two communities declaring a state of emergency as water poured into homes, creating moats around their foundations and leading to boat rescues of residents. Concern about a dam listed in poor condition led to more evacuations.
The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient.
Hurricane Lee, still a Category 3 storm with winds of 115 mph, is expected to increase in size but be significantly weaker in the coming days, as it turns north to reach the U.S. East Coast, according to the National Hurricane Center.
The U.S. approved updated COVID-19 vaccines Monday, hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter.
An earthquake has sown destruction and devastation in Morocco, where death and injury counts continue to rise as rescue crews dig out people both alive and dead in villages that were reduced to rubble.
Hurricane Lee whipped up waves of more than 15 feet (5 meters) on Monday as the Category 3 storm cranked through open waters just north of the Caribbean region.
