Tag: Food and Drug Administration
LabCorp COVID-19 test kit has just been approved for sale over-the-counter
LabCorp has now become the first company to receive approval to sell its COVID-19 test kit over-the-counter without a prescription, according to a statement from the company. One of the largest diagnostics testing companies in the U.S., LabCorp could be a significant competitor to companies like EverlyWell, which received approvals…
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Everylwell gains first FDA authorization for a standalone at-home COVID-19 test sample collection kit
Everlywell was one of the first startups to announce that it was working on a self-administered, at-home COVID-19 diagnostic kit, but it initially sought out to ship kits before regulators made clear that this was not in line with its guidelines. Everlywell then became intent on working with the FDA…
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FDA authorizes a ventilator developed by NASA’s JPL for emergency use in COVID-19 treatment
The U.F. Food and Drug Administration (FDA) has authorized a new ventilator designed by engineers working at NASA’s Jet Propulsion Laboratory, for emergency use as outlined in the agency’s COVID-19 guidelines. The ventilator, which has an acronym because this is NASA we’re talking about, is called ‘VITAL’ (Ventilator Intervention Technology…
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FDA reiterates risks of antimalarial drug use for COVID-19, as study into efficacy ends early due to deaths
The U.S. Food and Drug Administration (FDA) has issued a new warning about the known side effects of hydroxychloroquine and chloroquine, two antimalarial drugs (also used in the treatment of chronic rheumatoid arthritis and lupus), on the same day that a group of researchers published a paper in the Journal…
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LabCorp’s at-home COVID-19 test kit is the first to be authorized by the FDA
LabCorp’s at-home COVID-19 test, which is called ‘Pixel,’ has received the first Emergency Use Authorization (EUA) for such a test missed by the U.S. Food and Drug Administration (FDA). The test is an at-home collection kit, which provides sample collection materials including a nasal swab to the user, who then…
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Spiro Wave emergency ventilator gains FDA authorization to address COVID-19 demand
A new project designed to help address the growing need for ventilator hardware in order to treat the most serious cases of COVID-19 achieved an important milestone today, getting FDA Emergency Use Authorization (EUA) for its units to be used and scaled for production. The hardware, dubbed ‘Spiro Wave,’ is…
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