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.”
U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops.
The Webb Space Telescope is marking one year of cosmic photographs with one of its best yet: the dramatic close-up of dozens of stars at the moment of birth.
Floodwaters receded in Vermont cities and towns pummeled by a storm that delivered two months of rain in two days, enabling people to focus Wednesday on recovering from a disaster that trapped residents in homes, closed roadways and choked streets and businesses with mud and debris.
Schools in New Delhi were forced to close Monday after heavy monsoon rains battered the Indian capital, with landslides and flash floods killing at least 15 people over the last three days. Farther north, the overflowing Beas River swept vehicles downstream as it flooded neighborhoods.
Even Southwestern desert residents accustomed to scorching summers are feeling the grip of an extreme heat wave smacking Arizona, Nevada, New Mexico and Southern California this week with 100-degree-plus temps and excessive heat warnings.
