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    FDA debuts new clinical support software draft guide, backs off certain regulations

    The agency also issued a plan clarifying the regulation of certain digital health products such as mobile applications and finalized guidance on Software as a Medical Device.

    By David Lim • Dec. 8, 2017
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    Hospitals facing IV solution shortages after Hurricane Maria

    The FDA has granted one of the largest manufacturers of IV solutions permission to import IV bags from its facilities in other countries.

    By David Lim • Nov. 16, 2017
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Explore the Trendline➔
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    Top 5 stories from MedTech Dive

    From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    New alliance aims to advance digital therapeutics

    Founding members include Akili Interactive, Propeller Health, Voluntis and WellDoc.

    By Meg Bryant • Oct. 27, 2017

  • FDA unveils digital health pilot program to speed up certification process

    The agency also published its Digital Health Innovation Action Plan, which provides detail and timelines related to digital health and the 21st Century Cures Act.

    By Jeff Byers • July 27, 2017

  • Anthem to pay record $115M to settle data breach lawsuit

    The payer agreed to set aside funding for cybersecurity improvements, as well as cover two years of credit protection and $15 million worth of out-of-pocket costs for those affected.

    By Shannon Muchmore • Updated Aug. 16, 2018