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 first image of a black hole captured in 2019 is getting a makeover. Researchers on Thursday revealed an updated version, which they made using artificial intelligence.
Some abortion clinics are fielding lots of calls from patients since a court ruling last Friday threatened the availability of a main drug used in medication abortion, mifepristone.
The Biden administration released an environmental analysis Tuesday that outlined two ways that seven Western states and tribes reliant on the over-tapped Colorado River could cut their use, but declined to publicly take a side on the best option.
Scientists have found a hidden chapter of Bible text written more than 1,500 years ago. They uncovered the scripture after applying ultraviolet light to a manuscript about ancient Christian stories and hymns housed at the Vatican library.
