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.”
Nearly a day after being downgraded from a tropical storm, Ophelia still threatened parts of the Northeast on Sunday with coastal flooding, life-threatening waves and heavy rain from Washington to New York City, the National Hurricane Center said.
Surgeons have transplanted a pig’s heart into a dying man in a bid to prolong his life – only the second patient to ever undergo such an experimental feat. Two days later, the man was cracking jokes and able to sit in a chair, Maryland doctors said Friday.
Tropical Storm Ophelia formed off the mid-Atlantic coast and was expected to bring heavy rain, storm surge and windy conditions over the weekend, the National Hurricane Center said Friday.
A storm churning in waters off the eastern U.S. has increased to tropical storm strength and is forecast to reach the North Carolina coast Friday morning, the National Hurricane Center said.
