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FDA Approves Samsung's Irregular Heart Rhythm Notification Tool

Source: Samsung Electronics

Samsung Electronics (KRX: 005930) has announced FDA clearance of the Irregular Heart Rhythm Notification (IHRN) feature, an addition to the Samsung Health Monitor app.

This tool, paired with the app's electrocardiogram (ECG) function, enables monitoring of heart rhythms that indicate atrial fibrillation (AFib) directly from the user's wrist.

"This is another example of how Samsung is prioritizing proactive safety solutions and enabling users to gain a more holistic understanding of their cardiovascular and overall health," said Hon Pak, vice president and head of the Digital Health Team, MX Business at Samsung Electronics.

Cardiovascular disease, a leading cause of death worldwide, is often associated with AFib arrhythmia.

In addition, AFib can signal severe cardiovascular complications, including an increased risk of stroke and heart failure.

However, some cases of AFib are asymptomatic, leaving people unaware of their potential danger.

The Galaxy Watch provides tools to help users better understand their heart health. These include on-demand ECG recording and HR Alert, which detects abnormal heart rates.

The new IHRN feature now adds another health monitoring aspect for Galaxy Watch users.

Once activated in the Samsung Health Monitor app, the IHRN feature checks for irregular heart rhythms via the Galaxy Watch's BioActive Sensor.

If multiple consecutive readings indicate an irregularity, the Galaxy Watch will alert the user of potential atrial fibrillation activity and prompt them to take a more accurate ECG on their watch.

This IHRN feature will be included in the newly announced One UI 5 Watch, initially available on upcoming Galaxy Watch devices later this year, with plans to expand to earlier models.