Apple Watch获中国药监局批准，房颤历史记录功能上线

DoNews03-06

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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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。其适用对象为已确诊房颤、年龄22岁及以上的用户，不用于健康人群的疾病筛查。相较于原有移动心电图（ECG）功能仅支持30秒单次快照式检测，“房颤历史记录”实现接近连续的长期监测，填补患者就诊时症状消失、常规检查难以捕获异常的临床空白。数据显示，房颤负荷低于2%可能仅需观察；超过10%则提示可能需调整抗凝治疗或评估射频消融手术指征。审批过程要求Apple在国内医疗机构开展针对中国人群肤色、体型及生理特征的算法有效性与安全性验证，区别于普通消费电子产品的3C认证，体现中国对诊断辅助类功能的严格监管路径。该功能支持家庭健康共享，允许授权家人远程查看房颤负荷趋势，结合睡眠时长、酒精摄入量、运动时间等生活方式数据同屏可视化呈现，辅助识别行为因素与心脏节律变化的潜在关联。例如，用户可直观观察到某次饮酒后次日房颤负荷显著升高。尽管获得医疗器械资质，Apple Watch仍不具备全导联动态心电图（Holter）的波形采集能力，其数据不可替代专业诊疗设备。官方明确标注其定位为已确诊患者的长期管理工具，强调提升患者依从性与医患沟通效率，而非替代医生诊断。截至当前，该功能已随最新版watchOS更新推送至符合硬件条件的国行Apple Watch Series 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