查看完整版本: [-- GE研发阿尔兹海默症成像设备获得FDA批准 --]

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医疗器械 2013-12-14 14:09

2013年10月30日讯 /SciFans.net/ --GE Healthcare公司宣布公司研制的用于帮助评估阿尔兹海默症患者以及痴呆症患者病情的脑成像系统设备获得FDA审核通过。这种设备是通过先向患者注射一种名为Vizamyl的放射性诊断药物后再扫描患者脑部检测淀粉样蛋白质浓度来确定患者病情的。(SciFans.net)
详细英文报道:
GE Healthcare ($GE) has gained FDA approval for an imaging agent designed to help evaluate patients for Alzheimer's disease or dementia. Regulators announced the approval, which designates flutemetamol--now called Vizamyl--as a "radioactive diagnostic drug" for use in PET imaging of the brain in s being scrutinized for either condition. Patents are injected with the agent before PET scans designed to detect beta amyloid deposits in the brain, which are widely believed to be red flags for Alzheimer's development. Vizamyl attaches to the beta amyloid. Last year, GE licensed the agent to Merck ($MRK) for use on select trial participants for MK-8931, Merck's hoped-for Alzheimer's blockbuster drug.



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