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The Bleeding Edge is a 2018 Netflix original documentary film that investigates the $400 billion medical device industry. [1] Written and directed by Kirby Dick and produced by Amy Ziering and Amy Herdy, it premiered at the 2018 Tribeca Film Festival, where it was billed as "the stuff of dystopian nightmares". [2]
In March 2020, the company announced a rapid diagnostic test for SARS-CoV-2; the U.S. FDA granted an emergency use authorization for the test. [19] The diagnostic is designed to run on any of the (over 23,000) existing Cepheid GeneXpert machines worldwide, with the standard 45 minute detection time.
The 2002 Medical Device User Fee and Modernization Act (MDUFA) first granted FDA the authority to collect user fees from industry to help the FDA improve efficiency, quality, and predictability of medical device submission reviews; the medical device user fee program has been reauthorized several times with the most recent in 2022.
A medical device company has agreed to pay $42 million and plead guilty to resolve U.S. charges that it concealed a malfunction in its lead-testing devices that resulted in thousands of children ...
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Its Biopharma Laboratory Services segment provides drug development, medical device and diagnostic development services to pharmaceutical, biotechnology, medical device, and diagnostic companies. [1] In 2023, this division provided support to 84% of the new drugs and therapeutic products approved by the Food and Drug Administration. [1]
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