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Samsung Galaxy Watch Active 2 cleared for ECG monitoring in its home market

By Nadeem Sarwar May 24, 2020, 2:16 pm

Samsung has announced that it has received clearance for the ECG function in Samsung Health Monitor app by South Korea’s Ministry of Food and Drug Safety (MFDS). What this means is that the ECG sensor on the Galaxy Watch Active 2 can now be used for analyzing heart rhythm for abnormalities such as Atrial Fibrillation (AFib).

AFib is among the leading causes for strokes, and also increases the risk of complications such as blood clots and heart failure among others. However, it must be noted that the ECG monitoring feature is limited to the Galaxy Watch Active 2 via the Samsung Health Monitor app. However, it will likely be available on its successors too.


A month ago, the Samsung Health Monitor app too was cleared by MFDS for monitoring blood pressure, classifying it as a “Software as a Medical Device (SaMD)” product. Thanks to the nod from the regulatory body, the Galaxy Watch Active 2 could be marketed as a government-cleared, cuff-less device for monitoring blood pressure levels.

Source: Samsung


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