Phillips Electronics North America Corp. has recalled 71 HeartStart MRx defibrillators produced in September and October 2016 due to a defect that may cause the device to fail, the Food and Drug Administration announced Friday. If used in automated external defibrillator mode after failing, the device will not delivery patient therapy, which may lead to serious patient injury or death, the agency said. For more information and a list of affected devices, see the FDA notice.
The Food and Drug Administration Friday released draft guidance on how drug developers can apply for the agency’s Competitive Generic Therapies designation.
Hospitals and clinicians are seeing fewer flu patients this season than in other recent years, the Centers for Disease Control and Prevention reports.
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Members of the pharmaceutical distribution supply chain, including dispensers such as hospitals and pharmacies, can apply through March 11 to participate in a…
The U.S. District Court for the Western District of Pennsylvania has entered a consent decree prohibiting Ranier’s Rx Laboratory Inc. from manufacturing or…
The Food and Drug Administration Friday warned physicians and patients who use medical devices to monitor levels of the blood thinner warfarin that certain…