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Medical News

Burst Balloons Force TAVR Device Recall

]]>(MedPage Today) -- Just days after expanding the indication for Edwards Lifesciences' Sapien 3 and other transcatheter aortic valve replacement (TAVR) devices, the FDA announced a Class I recall on the Sapien 3 Ultra delivery system. The recall...

Morning Break: Canada Balks at Drug Exports; Heat Wave Threat; Opioid 'Villains'

]]>(MedPage Today) -- Note that some links may require subscriptions. Proposals to import drugs from Canada face opposition from a crucial stakeholder: Canada. (Reuters) With a massive heatwave baking much of the U.S., the American Heart Association...

First Cardiac MRI Contrast Agent Approved

]]>(MedPage Today) -- FDA approved gadobutrol (Gadavist) as the first contrast agent for cardiac MRI, manufacturer Bayer announced. The gadolinium-based injection is indicated to assess myocardial perfusion and late gadolinium enhancement in adults...

FDA: Beware of Faulty Platelet Counts From B-C Analyzers

]]>(MedPage Today) -- WASHINGTON -- The FDA alerted hospitals and clinical labs Thursday that a Class I recall has been declared for certain Beckman Coulter blood analyzers because they may provide inaccurate platelet counts. "[W]e are urging health...

FDA Loosens Alcohol Warning for Addyi

]]>(MedPage Today) -- WASHINGTON -- Drinking alcohol with the female libido booster flibanserin (Addyi) appears somewhat less dangerous than initially thought and the FDA has ordered a label change to reflect the new data -- over the manufacturer...