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Theranos Inc. (/ ˈ θ ɛr. ə n. oʊ s /) was an American privately held corporation [5] that was touted as a breakthrough health technology company. Founded in 2003 by then 19-year-old Elizabeth Holmes, Theranos raised more than US$700 million from venture capitalists and private investors, resulting in a $9 billion valuation at its peak in 2013 and 2014.
Elizabeth Anne Holmes (born February 3, 1984) is an American biotechnology entrepreneur who was convicted of fraud in connection with her blood-testing company, Theranos. [2] The company's valuation soared after it claimed to have revolutionized blood testing by developing methods that needed only very small volumes of blood, such as from a ...
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 ...
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.
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]
Industrial Bio-Test Laboratories (IBT Labs) was an American industrial product safety testing laboratory. [1] [2] [3] IBT conducted significant quantities of research for pharmaceutical companies, chemical manufacturers and other industrial clients; at its height during the 1950s, 1960s, and 1970s, IBT operated the largest facility of its kind and performed more than one-third of all ...
The Healy is a pseudoscientific device that claims to function via bioresonance, designed by Marcus Schmieke and Nuno Nina. [1] The device has been promoted via influencer marketing and multi-level marketing, while sellers make extreme healing claims without any proven benefits.
In the United States, medical and food test products are regulated by the Food and Drug Administration (FDA). [1] [2]Title 21 "Food and Drugs" , Part 50 "Protection of Human Subjects" defines test article as "drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation ...