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.”
Drugmaker giant Eli Lilly CEO Dave Ricks said during a Senate Committee hearing that the company will not raise the price of insulin products.
New blood donations rules will allow sexually active gay and bisexual men in monogamous relationships to give in the FDA guidelines ease decades-old restrictions put in place to protect the blood supply from HIV.
A new study finds an experimental skin patch shows promise to treat toddlers who are highly allergic to peanuts.
Britain's fertility regulator on Wednesday confirmed the births of the U.K.'s first babies created using an experimental technique combining DNA from three people, an effort to prevent the children from inheriting rare genetic diseases.
Federal health advisers said Wednesday that a decades-old birth control pill should be sold without a prescription, paving the way for a likely U.S. approval of the first over-the-counter contraceptive medication.
Colette Morales, instructor at Core 95, joined Cheddar News to teach a few basic yoga poses aimed at strengthening multiple areas of the body simultaneously.
A group of nationally-recognized medical experts are suggesting women start getting breast cancer screening at 40 years old.
The Food and Drug Administration is kicking off a two-day meeting to consider whether to let people get birth control pills without a prescription, with a decision expected by the summer.
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