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FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
Recalled masks were worn by thousands of Quebec kids; feds say import rule wasn't followed montreal.ctvnews.ca - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from montreal.ctvnews.ca Daily Mail and Mail on Sunday newspapers.
Share this article Share this article SILVER SPRING, Md., March 5, 2021 /PRNewswire/ Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription. The authorization of this new diagnostic test underscores FDA s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans, said Acting FDA Commissioner Janet Woodcock, M.D. The FDA will continue to expand Americans access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States. ....
Adobe In early May, a wing of Ohio State University’s Wexner Medical Center was eerily empty. The space had been cleared of patients as the pandemic raged. But it wasn’t going to waste. Inside, a group of nurse practitioners were playing a game of digital tag. Lauren Chrzanowski, who has type 1 diabetes, was wearing a continuous glucose monitor, an implant with a transmitter that sends real-time glucose measurements to a dedicated receiver when they’re close enough, anyway. On that day, she was trying to figure out just how far away her CGM could be from its receiver and still work. ....
Bill Clark / CQ-Roll Call, Inc via Getty Imag Nearly a year into the US pandemic, the massive startup Curative is embroiled in an ongoing argument with federal regulators: Is it worth having tests that may accurately detect COVID-19 in the early stages of infection, but not as time goes on? That debate came to a head this month when the Food and Drug Administration warned the public that the Southern California company’s tests were possibly missing coronavirus infections. This week, Curative pushed back with new data that, it claims, validates its approach. Research done by Curative suggests that its mouth-swab test spots the virus with a high degree of accuracy in the first three weeks of an infection, including in people without symptoms, and with less accuracy for later-stage infections. That drop-off in ability is relatively unimportant during the pandemic, Curative argues, underscoring a philosophical split in testing. ....