Samsung Galaxy Devices Get FDA Approval for ECG Monitoring Function

When it was released in 2019, the Samsung Galaxy Watch Active 2 included hardware support for ECG or Electrocardiogram monitoring, as did the Samsung Galaxy Watch 3 this year.

Android Police indicated in a review that the ECG monitoring feature could not be enabled in the United States until it got the Food and Drug Administration's approval, which leads to one of the main selling points of the watch not officially working in the United States.

Finally, one of the leading tech companies worldwide got the FDA's approval, and the ECG monitoring support has rolled out to both the Watch3 and Active2.

The watches' functionality was approved for use earlier this year in South Korea. As such, it can measure a user's heart rhythm for indications of some irregularities.

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Samsung Health Monitor App Required

For the ECG monitoring support to work with the two watch models, one needs to install the "Samsung Health Monitor" app on their mobile phone.

To use the feature, a user rests his arm on a flat surface and places his finger on the watch's top button.

In its announcement, Samsung said that users could already record appropriate symptoms such as dizziness or fatigue once the reading has been completed and send a report of their ECG recording in PDF format to their healthcare provider.

One important thing to note, according to the company, is that the Health Monitor App works only with Samsung Galaxy phones. However, the watch is generally compatible with most Android and even iOS devices.

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The ECG Feature

According to the tech firm, the ECG feature utilizes advanced sensor technology on both the Galaxy Watch3 and Active2. It will also allow a user to measure and analyze his heart rhythm for possible irregularities signaling AFib or Atrial Fibrillation.

The company also said one would receive the ECG readings by opening the Health Monitor app, placing his arms on a flat surface, and pressing his finger on the Watch Active2 or Watch3's top part for 30 seconds straight.

The mobile app will then check the user's heart rate and rhythm and validate if the heart is beating normally or abnormally.

Both models have the ability as well to read blood pressure, although this functionality, according to reports, would require an external cuff for standardization at least every four weeks.

Another essential feature one can find useful in a Samsung Galaxy Watch3 or Watch Active 2 is the tracker for blood oxygen levels.

In its description of the watches on its website, Samsung said three possible results a user can get from the ECG monitoring functionality.

These are the sinus rhythm that indicates if the heart is beating in the normal rhythm, which has a heart rate from 50 to 100 BPM; the atrial fibrillation showing if the heart was beating with abnormal rhythm; and an inconclusive report indicating that the heart was beating in an unclassified rhythm.

Before the ECG functionality and blood pressure monitoring got enabled in the US, they were initially limited to South Korea.

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