Samsung's smartwatch ECG feature gets green light in South Korea

The latest feature can now be combined with Samsung's cuffless blood pressure monitoring feature, which got approval in South Korea a few weeks ago.
By Laura Lovett
02:55 pm

Samsung is the latest wearable company to enter the ECG monitoring space, following an announcement on Sunday that the function on its Health Monitoring app got the greenlight from South Korea’s Ministry of Food and Drug Safety. 

This means that Galaxy Watch Active2 users in South Korea will be able to use the tool to detect any heart rhythm irregularities, which could be linked to AFib. 

It’s no secret Samsung has been pushing health features hard in the last few months. In April it scored an MFDS clearance for its cuffless blood pressure monitor feature. The user must first calibrate the feature with a traditional cuff, then the wearable is able to measure blood pressure via pulse wave analysis that is tracked through heart rate monitoring sensors, according to the company. 

Customers in South Korea will be able to digitally send both their ECG and blood pressure measurements to their doctor. According to the company, the new feature will be available on the Galaxy Watch Active2 sometime in the third quarter and will eventually be expanded to the new Galaxy Watches coming down the pipeline.


While the ECG and blood pressure monitoring features are only available in South Korea, it’s hard not to speculate that the tech will be making its way across the Pacific to the U.S. markets and beyond. This will mean seeking FDA clearance and a CE mark for Europe. 

However, the demand for heart health tools in these markets remains there. Afib impacts between 2.7 million and 6.1 million people in the United States and that number is expected to grow, according to the CDC

Samsung is pitching this tool as a way to get insights into both blood pressure and heart health.  

“When you pair the advanced hardware of Galaxy watches with innovative software solutions, you can create unmatched experiences – such as, in this case, convenient and accessible health check-ins for millions of users across the world,” TaeJong Jay Yang, corporate SVP and head of the health team, mobile communications business at Samsung Electronics, said in a statement. “This marks just one way in which Samsung is pioneering to give everyone a simple, convenient and informed picture of their overall health and wellness.”


The race for ECG features in smart watches began with Apple’s 2018 announcement that its Series 4 Watch had scored FDA clearance for its built-in ECG. 

In January, Withings unveiled its latest smartwatch that included both an ECG feature and Sp02 capabilities – however, the ECG feature is still under review with the FDA. Withings is also interested in the blood pressure monitoring space. Last year it unveiled a connected blood pressure cuff product line with a revamped version of its existing at-home cuff, and a premium cardiac monitor with onboard ECG functionality.

It’s not just traditional consumer wearable companies interested in the space. In August Tel Aviv, Israel-based Biobeat scored 510(k) clearance for a remote-monitoring device capable of measuring the wearer’s blood pressure, oxygenation and heart rate.

But perhaps Omron has the closest functional abilities. It scored a 510(k) clearance for its Blood Pressure Monitor + EKG device in March of 2019, nearly a year after it was originally unveiled. However, unlike Samsung’s tool it is not cuffless. 


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