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Category: FDA


FDA gives Quest EUA for their at-home sample collection kit for COVID-19 testing; Plans to produce 500k units by end of June

William Feuer CNBC Author Healthcare HandoutPosted on May 29, 2020May 29, 2020Categories Commercial Labs, COVID-19, FDATags Quest Diagnostics Go Deeper
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FDA says it abruptly shut down Gates-backed Seattle coronavirus study for lacking EUA, institutional review board ethics approvals

Erin Brodwin STAT Author Healthcare HandoutPosted on May 27, 2020May 27, 2020Categories COVID-19, FDA Go Deeper
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Philips gets FDA 510(K) clearance for Biosensor BX100; Disposable chest patch that lets providers remotely monitor patient heart and respiratory rates

Elise Reuter MedCityNews Author Healthcare HandoutPosted on May 26, 2020May 26, 2020Categories FDATags Philips Go Deeper
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Stericycle predicts a surge in medical device recalls starting in Q3 as FDA Emergency Use Authorizations and enforcement-discretion end

Alia Paavola Becker's Hospital Review Author Healthcare HandoutPosted on May 21, 2020May 21, 2020Categories Medical Devices, FDATags Stericycle
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FDA partners with Aetion to launch real-world evidence study for COVID-19 diagnostics and treatments

Matthew Herper STAT Author Healthcare HandoutPosted on May 19, 2020May 19, 2020Categories FDA, COVID-19, ResearchTags Aetion
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FDA abruptly orders Seattle Coronavirus Assessment Network, a Gates-backed initiative to do broad coronavirus testing, to stop performing tests and reporting results pending review

Mike Baker The New York Times Author Healthcare HandoutPosted on May 15, 2020May 15, 2020Categories FDA, COVID-19
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FDA pulls approval for 60+ mask makers in China after discovering products don't meet safety standards

Austen Hufford, Mark Maremont The Wall Street Journal Author Healthcare HandoutPosted on May 7, 2020May 7, 2020Categories FDA, Supply Chain Go Deeper
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FDA grants EUA for Sherlock Biosciences' CRISPR-based coronavirus test; First CRISPR product through the FDA

Alaric DeArment MedCityNews Author Healthcare HandoutPosted on May 7, 2020May 13, 2020Categories Biotech, COVID-19, FDA, GovernmentTags Sherlock Biosciences Go Deeper
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FDA reverses course, will now require coronavirus antibody tests to receive emergency use authorization; Only 12 tests have been authorized so far, 250+ are pending

Berkeley Lovelace Jr., William Feuer CNBC Author Healthcare HandoutPosted on May 4, 2020May 4, 2020Categories FDA, COVID-19, Government
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Hundreds Receive Plasma From Recovered Coronavirus Patients in National Study

Amy Dockser Marcus The Wall Street Journal Author Healthcare HandoutPosted on April 21, 2020April 21, 2020Categories COVID-19, FDA, Government
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Healthcare Handout Everything worth knowing in healthcare tech and business.
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