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.”
It’s been a month since a Maryland man became the second person to receive a transplanted heart from a pig –- and hospital video released Friday shows he’s working hard to recover.
CVS Health is pulling from its shelves some cough-and-cold treatments that contain an ingredient that has been deemed ineffective by doctors and researchers.
October is Breast Awareness Cancer Month as the disease affects millions of American families. Elissa Kalver, founder of Wegotthis.org, joined Cheddar News to explain how breast cancer inspired her to create her own nonprofit and provided some details of her personal battle while maintaining a family.
With warmer oceans serving as fuel, Atlantic hurricanes are now more than twice as likely as before to rapidly intensify from wimpy minor hurricanes to powerful and catastrophic, a study said Thursday.
