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.”
Riggs Eckelberry, CEO of OriginClear, which manufactures modular clean water systems, provided background on the water safety crisis in the U.S. He also provided best practices on how to test and filter water at home.
The Centers for Disease Control and Prevention is warning of a rare and mysterious deadly fungal infection that is spreading at an alarming rate around the country.
New research shows that exposure to polyfluoroalkyl substances (PFAS), also known as "forever chemicals" can hamper growth and development in children by "altering hormonal and metabolic pathways."
The Centers for Disease Control and Prevention (CDC) on Monday warned that a deadly fungus called Candida auris (C. auris) is spreading at an "alarming rate" in the U.S. healthcare facilities.
Karuna Therapeutics' top-experimental schizophrenia drug significantly reduced symptoms in a late-stage trial but there were concerns that it could cause hypertension in patients.
One of television's most successful writers made a big donation to the Cedars Sinai Medical Center in Los Angeles to help underserved community members gain the skills to become health care professionals.
The UN Intergovernmental Panel on Climate Change (IPCC) has released a new report providing multiple options for how the world can survive and adapt to climate change.
California Gov. Gavin Newsom over the weekend announced that the state has secured a contract with CIVCA to make $30 insulin available to all who need it. He also announced that the state will start manufacturing Naloxone, an emergency medication used to rapidly reverse the effects of an opioid overdose.
