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.”
Earth has pushed past seven out of eight scientifically established safety limits and into “the danger zone,” not just for an overheating planet that's losing its natural areas, but for the well-being of people living on it, according to a new study.
You've probably heard about respiratory viruses like RSV and the flu, but now doctors are saying a new virus is on the rise. Cases of human metapneumovirus, or HMPV, spiked this spring, according to the CDC. The virus causes many of the same symptoms as the flu , including coughing, runny nose, sore throat, and fever.
There's new information about the world's oldest flying reptile, which was discovered in Australia. The giant creature is known as a pterosaur and lived about 107 million years ago.
Food workers who showed up while sick or contagious were linked to about 40% of restaurant food poisoning outbreaks with a known cause between 2017 and 2019, federal health officials said Tuesday.
