Medical device: Latest News, Top Stories & Analysis

FTC Approves Final Order Imposing Conditions on Stryker Corp.’s Acquisition of Wright Medical Group N.V.

December 21, 2020December 18, 2020 - by MyChesCo

WASHINGTON, 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 …

FDA Launches the Digital Health Center of Excellence

September 24, 2020September 24, 2020 - by MyChesCo

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 …

Government / Medical Products / National

FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products

July 23, 2020July 23, 2020 - by MyChesCo

The 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).

Government / Medical Products

37 PA Mayors Call for Federal Government to Increase Production of Medical Supplies and Coordinate Distribution to Save Lives

April 6, 2020April 6, 2020 - by MyChesCo

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 …

Health / Medical / National / Technology

FDA Informs Patients, Providers and Manufacturers About Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy

March 6, 2020March 5, 2020 - by MyChesCo

WASHINGTON, 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 …