Chester County News and Community Website
NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq: HSDT) (TSX: HSM) announced that it has received Breakthrough Designation from the U.S. Food and Drug Administration (“FDA”) for its PoNS™ device …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration this week announced participation in several new collaborative communities aimed at addressing challenges in patient health care. Collaborative communities are a continuing …
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WASHINGTON, D.C. — The following quote is attributed to William Maisel, M.D., director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health:
Read More WASHINGTON, D.C. — The following quote is attributed to William Maisel, M.D., chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices …
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WASHINGTON, D.C. — The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health:
Read MoreWASHINGTON, D.C. — Following a public comment period, the Federal Trade Commission recently approved a final order settling charges that medical device company Stryker Corp.’s proposed $4 billion acquisition of competitor …
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The U.S. Food and Drug Administration recently announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital …
Read MoreThe U.S. Food and Drug Administration is extending the enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps).
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PHILADELPHIA, PA — More than 30 mayors from across Pennsylvania were among 113 city leaders nationwide petitioning the federal government to use its emergency powers to ramp up production of …
Read MoreWASHINGTON, D.C. — The U.S. Food and Drug Administration is informing patients, health care providers and manufacturers about a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that – if …
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