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  2. Theranos - Wikipedia

    en.wikipedia.org/wiki/Theranos

    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.

  3. OraSure Technologies - Wikipedia

    en.wikipedia.org/wiki/OraSure_Technologies

    OraSure Technologies, Inc. is a Bethlehem, Pennsylvania–based company in the medical device industry. Their products include diagnostic testing kits. The company had recently developed OraQuick testing kit, the first over-the-counter home HIV test. [1] [2] [3] [4]

  4. 15 Biggest Medical Device Companies in the World - AOL

    www.aol.com/news/15-biggest-medical-device...

    14. Penumbra, Inc. (NYSE:PEN) Market Cap as of November 18: $7.34 B . Number of Hedge Fund Holders: 27. Penumbra, Inc. (NYSE:PEN) is a medical device company that manufactures products for the ...

  5. FDA Center for Devices and Radiological Health - Wikipedia

    en.wikipedia.org/wiki/FDA_Center_for_Devices_and...

    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.

  6. FDA staff were reviewing Elon Musk’s brain implant company ...

    www.aol.com/fda-staff-were-reviewing-elon...

    Neuralink is currently testing its device, which allows paralyzed people to use digital devices solely via thought, in a small number of disabled patients. The company is also working on an ...

  7. Medical device company to pay $42 million to resolve US lead ...

    www.aol.com/news/medical-device-company-pay-42...

    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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