已開啟。八幡 wrote:有沒有FDA 認證??2025年9月就取得FDA許可
如果沒有的話只是測個心安而已!!
當時申請但書如下
高⾎壓通知功能 (HTNF) 是一款純軟體⾏動醫療應用程序,它分析 Apple Watch 隨機收集的光電容積脈搏波描記法 (PPG) 數據,以識別提示高⾎壓的模式,並向用戶發出通知。
此功能適用於22歲及以上、先前未被診斷為高⾎壓的成年人,無需處方即可使用。它不能取代傳統的診斷方法,也不能用於監測高⾎壓治療效果或作為⾎壓監測手段。孕婦禁用。未收到通知不代表未患高⾎壓
The Hypertension Notification Feature (HTNF) is a software-only mobile medical application that analyzesphotoplethysmography (PPG) data opportunistically collected by Apple Watch to identify patterns that are suggestive of hypertension and provides a notification to the user.
The feature is intended for over-the-counter (OTC) use by adults age 22 and over who have not been previously diagnosed with hypertension. It is not intended to replace traditional methods of diagnosis, to monitor hypertension treatment effect, or to be used as a method of blood pressure surveillance. It is not
intended for use during pregnancy. The absence of a notification does not indicate the absence of hypertension.
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感謝分享&介紹,很實用的功能,不知耗電影響有多少 

























































































