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 global bottled water industry is booming, and it's coming at a steep environmental cost, according to the United Nations University Institute for Water, Environment and Health.
A new gel that helps stop bleeding for both emergency care and surgical procedures in animal medicine is being sought for FDA approval for a human version.
In this photo provided by Henry Danner, Omari Maynard sits with his children, Khari, left, and, Anari, holding a photo of their late mother, Shamony Gibson, at home in the Brooklyn borough of New York on April 9, 2022. Gibson passed away in 2019, two weeks after giving birth to Khari due to a pulmonary embolism. “She wasn’t being heard at all,” said Maynard, an artist who now does speaking engagements as a maternal health advocate.
The Environmental Protection Agency has proposed a new plan to lower the cap on the amount of harmful "forever chemicals" allowed in drinking water across the country.
Dr. Joel Salinas, clinical assistant professor of neurology at NYU Langone Health and chief medical officer at Isaac Health, spoke with Cheddar News anchor Shannon LaNier about Alzheimer's disease and struggles to find an effective treatment.
