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U.K.medicinesandhealthcareproductsregulatoryagency

Medtech manufacturers must add warning label to drug-eluting PAD devices

June 16, 2020 By Nancy Crotti

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]

Filed Under: Business/Financial News, Drug-Device Combinations, Drug-Eluting Stents, Featured, Regulatory/Compliance, Stents, Vascular Tagged With: B. Braun, Biosensors International Group Ltd., Biotronik, Boston Scientific, Cook Medical, FDA, Lutonix Inc., LVD Biotech, Medtronic, Spectranetics Corp., U.K.medicinesandhealthcareproductsregulatoryagency

Philips recalls lithium-ion defibrillator batteries

November 30, 2018 By Nancy Crotti

Philips Healthcare has issued a worldwide recall of batteries for its HeartStart MRx monitor/defibrillator. The Philips M3538A lithium-ion batteries manufactured from December 28, 2017 to March 20, 2018 for the HeartStart MRx monitor/defibrillator may have an internal component failure and may fail to charge or to provide power, according to a statement by the U.K. Medicines and […]

Filed Under: Business/Financial News, Recalls, Regulatory/Compliance, Structural Heart Tagged With: Philips, U.K.medicinesandhealthcareproductsregulatoryagency

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