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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]
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.
Medtronic plc is an American-Irish medical device company. The company's operational and executive headquarters are in Minneapolis, Minnesota, and its legal headquarters are in Ireland due to its acquisition of Irish-based Covidien in 2015.
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Direct-to-consumer tests are regulated as medical devices, although they are not necessarily reviewed by the FDA. [8] 23andMe direct-to-consumer genetic tests were originally offered as LDTs, but the FDA challenged that and forced the company to submit the test for approval as a class II medical device. [9] [10]
The functionalities that Applied Spectral Imaging provides laboratories and hospitals include automated slide scanning, applications interface, whole slide imaging, scoring and analysis, sharing capabilities for team review and final sign off, database management, secure archiving of reports, connectivity to the LIS and standardized testing.
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