Apple Watch获中国药监局批准,房颤历史记录功能上线

DoNews
Mar 06

Apple Watch“房颤历史记录”功能已通过中国国家药品监督管理局审批,正式作为第二类医疗器械在国内启用。该功能在海外发布两年后完成本地化临床验证与注册,标志着可穿戴设备在中国从消费电子产品升级为具备临床参考价值的医疗辅助工具。该功能基于光电容积脉搏波(PPG)技术,无需用户主动操作,可周期性监测心律并计算过去七日内房颤负荷(AFib Burden),即房颤持续时间占总时长的百分比。其适用对象...

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