FDA authorizes Moderna’s COVID-19 vaccine for emergency use – ITPro.works

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, as expected after an independent panel commissioned by the administration recommended its … Read More

FDA grants emergency use authorization for Pfizer’s COVID-19 vaccine, distribution to begin within days – ITPro.works

The U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for the COVID-19 vaccine developed by Pfizer and its partner BioNTech, the New York Times first … Read More

FDA panel recommends approving Pfizer’s COVID-19 vaccine emergency use authorization – ITPro.works

An independent panel of experts has recommended the Food and Drug Administration (FDA) approve an official Emergency Use Authorization (EUA) for the Pfizer and BioNTech COVID-19 vaccine. This means that … Read More

Moderna claims 94% efficacy for COVID-19 vaccine, will ask FDA for emergency use authorization today – ITPro.works

Drugmaker Moderna has completed its initial efficacy analysis of its COVID-19 vaccine from the drug’s Phase 3 clinical study, and determined that it was 94.1% effective in preventing people from … Read More

AliveCor, which helps its users manage their heart health, scores another FDA approval – ITPro.works

Last week, AliveCor, a nine-year-old, 92-person company whose small, personal electrocardiogram devices help users detect atrial fibrillation, bradycardia, and tachycardia from heart rate readings taken from their own kitchen tables, … Read More

Cue Health’s portable, fast COVID-19 test gains FDA emergency approval – TechCrunch

Fresh off a $100 million Series C funding round, molecular diagnostics startup Cue Health has more good news — it has received an Emergency Use Authorization (EUA) for its rapid, … Read More

Everylwell gains first FDA authorization for a standalone at-home COVID-19 test sample collection kit – TechCrunch

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 … Read More

Formlabs gets FDA emergency use authorization for a 3D-printed ventilator conversion part – TechCrunch

The U.S. Food and Drug Administration has awarded Formlabs an emergency use authorization (EUA) for a 3D-printed part designed to convert BiPAP machines designed for sleep apnea into much-needed ventilators. The … Read More

FDA authorizes a ventilator developed by NASA’s JPL for emergency use in COVID-19 treatment – TechCrunch

The U.S. Food and Drug Administration (FDA) has authorized for emergency use as outlined in the agency’s COVID-19 guidelines a new ventilator designed by engineers working at NASA’s Jet Propulsion … Read More

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