Category: Food and Drug Administration
Curative received FDA emergency use authorization for its novel COVID-19 tests
The diagnostics startup Curative has received an emergency use authorization from the Food and Drug Administration for its novel test to determine COVID-19 infection. The company says that its tests have already been used by the City of Los Angeles since late March and have tested over 53,000 city residents.…
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FDA authorizes production of a new ventilator that costs up to 25x less than existing devices
The U.S. Food and Drug Administration (FDA) has authorized the manufacture of the Coventor ventilator, a new hardware design first developed by the University of Minnesota. The project sought to create a ventilator that could provide the same level of life-saving care as existing ventilator models, but with a much…
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Venture-backed Celularity receives FDA approval for early trials of a new cell therapy for COVID-19
Celularity, the venture-backed developer of novel cell therapies for cancer treatments, has received an initial clearance from the Food and Drug Administration to begin early-stage clinical trials on a potential treatment for COVID-19. The company, which has raised at least $290 million to date (according to Crunchbase), uses “Natural Killer”…
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FDA introduces a new program to expedite deployment of potential coronavirus treatments
The U.S. Food and Drug Administration (FDA) announced a new program today that’s designed to foster close collaboration between public and private organizations in order to “bring coronavirus treatments to market as fast as possible,” according to U.S. Department of Health & Human Services Secretary Alex Azar in a press…
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A new FDA-authorized COVID-19 test doesn’t need a lab and can produce results in just 5 minutes
There’s a new COVID-19 test from healthcare technology maker Abbott that looks to be the fastest yet in terms of producing results, and that can do so on the spot right at point-of-care, without requiring a round trip to a lab. This test for the novel coronavirus causing the current…
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Prisma Health develops FDA-authorized 3D-printed device that lets a single ventilator treat four patients
The impending shortage of ventilators for U.S. hospitals is likely already a crisis, but will become even more dire as the number of patients with COVID-19 that are suffering from severe symptoms and require hospitalization grows. That’s why a simple piece of hardware newly approved by the FDA for emergency…
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