苹果 Apple Watch“房颤历史”功能获国家药品监督管理局批准

IT之家01-09

IT之家 1 月 9 日消息，苹果 Apple Watch 的“房颤历史”功能获国家药品监督管理局批准进口医疗器械（注册）第二类资质。IT之家查询获悉，该功能的注册名称为“移动脉率房颤迹象记录软件”，于 2025 年 12 月 26 日正式获批。注册信息显示，该产品适用于 22 岁及以上已确诊房颤的患者，用于回顾性估算可能的房颤发作时长比例，该产品不提供单独的房颤迹象提示，也不能替代传统的诊疗方法...

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