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The WCD was extensively tested for three years in 17 major medical centers across the United States and Europe. The clinical data collected from those trials [26] allowed Lifecor to obtain FDA approval for use of the WCD in the United States. [citation needed] In 2001, the FDA approved the LifeVest wearable cardioverter defibrillator (model 2000).
The 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) enhanced FDA's ability to identify, prevent, and mitigate possible shortages of medical devices by requiring manufacturers to inform FDA of an interruption or permanent discontinuation of manufacturing during a public health emergency.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
A new type of internal heart defibrillator, ... could help younger patients live longer. ... The device was recently approved by the FDA to treat abnormal heart rhythms and sudden cardiac arrests ...
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The Food and Drug Administration will authorize the emergency use of the antiviral remdesivir on COVID-19 patients as soon as Wednesday, a senior administration official told The New York Times.
Health Protection (Face Coverings in a Relevant Place) (England) Regulations 2020; Health Protection (Coronavirus, International Travel) (England) Regulations 2020; The Health Protection (Coronavirus, Restrictions) (Self-Isolation) (England) Regulations 2020; First COVID-19 tier regulations in England; Second COVID-19 tier regulations in England
Late Friday night, the U.S. Food And Drug Administration approved the first coronavirus test that can be conducted entirely at the point of care for a patient and deliver results in 45 minutes ...