Samsung’s Galaxy Watch Obtains FDA Approval for Innovative Heart Rhythm Monitoring Feature

KEY TAKEAWAYS
Samsung's irregular heart rhythm notification feature for its Galaxy Watches has obtained clearance from the FDA, complementing the already FDA-cleared Electrocardiogram (ECG) function.
The feature closely resembles Fitbit's atrial fibrillation (AFib) monitoring and Apple's EKG spot-checks, but with the advantage of eliminating the need for user interaction.
The feature will be integrated into the upcoming One UI 5 Watch update, initially available for the soon-to-be-released Galaxy Watch 6 and later extended to earlier models.
Samsung aims to establish its Galaxy Watch devices as comprehensive health monitoring tools, but it still has ground to catch up with competitors like Fitbit and Apple.
The irregular heart rhythm feature is part of Samsung's comprehensive approach to cardiovascular health monitoring, along with other functions like on-demand ECG recording and HR Alert.
The feature is not intended for users diagnosed with other arrhythmias or those under the age of 22, and the absence of a notification should not be interpreted as the absence of a disease process.
Samsung's announcement comes amidst increasing competition in the smartwatch market, with the Pixel Watch gaining popularity and the upcoming updates for Wear OS 3.

 

Samsung has announced that its groundbreaking irregular heart rhythm notification feature for Galaxy Watches has received clearance from the Food and Drug Administration (FDA).

This latest development will complement the FDA-cleared Electrocardiogram (ECG) function and make its debut on the soon-to-be-released Galaxy Watch 6.

Enhanced Heart Monitoring in Line with Market Rivals

The irregular heart rhythm notification functionality of Samsung’s Galaxy Watch closely resembles Fitbit’s passive atrial fibrillation (AFib) monitoring feature, which was launched in the previous year.

It also bears similarities to Apple’s EKG spot-checks, first introduced in 2018. In contrast to EKG measurements, this novel feature eliminates the need for user interaction.

Once activated, the Galaxy Watch persistently observes irregular heart rate rhythms and only notifies users when a predetermined number of consecutive irregular measurements are identified. At this point, users are advised to take an EKG.

This innovative feature will be integrated into the forthcoming One UI 5 Watch update, initially unveiled by Samsung last week.

The update will first be made available for the soon-to-be-launched Galaxy Watch devices before being extended to earlier models, likely including the Galaxy Watch 4 and 5 series. 

Samsung intends to roll out a One UI 5 Watch beta for current Galaxy Watch 4 and 5 users later this month, though it remains uncertain whether the irregular heart rhythm feature will be part of the beta release.

Despite its initial challenges, Wear OS 3 is expected to receive updates at the Google I/O event this week, making the Android smartwatch arena more captivating than ever before.

Bridging the Gap with Industry Competitors

Samsung’s cutting-edge irregular heart rhythm notification feature aligns with the company’s mission to establish its Galaxy Watch devices as comprehensive health monitoring tools. 

However, it is clear that Samsung is still in the process of catching up to competitors such as Fitbit and Apple, who have already implemented similar features. 

For example, Apple introduced an FDA-cleared AFib History feature with watchOS 9, allowing users with irregular heart rate rhythms to monitor the duration of time spent in AFib.

Samsung’s announcement is timely, given that the Pixel Watch has become the second best-selling device in the market, with the upcoming Pixel Fold expected to intensify the competition further.

Despite its initial challenges, Wear OS 3 is expected to receive updates at the Google I/O event this week, making the Android smartwatch arena more captivating than ever before.

A Comprehensive Approach to Cardiovascular Health Monitoring

When activated in the Samsung Health Monitor app, the irregular heart rhythm notification feature employs the Galaxy Watch’s BioActive Sensor to continuously examine irregular heart rhythms in the background.

If a specific number of consecutive irregular measurements are detected, the smartwatch alerts users of potential AFib activity and prompts them to take an ECG for a more precise assessment.

Samsung highlights that this feature is not designed to provide notifications for every instance of irregular rhythm suggestive of AFib.

Additionally, the absence of a notification should not be interpreted as an indication that no disease process is present.

The feature is not intended for users diagnosed with other known arrhythmias or those under the age of 22.

The irregular heart rhythm notification feature will enhance the Galaxy Watch’s current health features utilizing the BioActive Sensor.

This includes on-demand ECG recording and an HR Alert function that identifies abnormally high or low heart rates.

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