The US FDA, Approved Irregular Heart Rhythm Notification for Samsung Galaxy Watch
The US FDA, Approved Irregular Heart Rhythm Notification for Samsung Galaxy Watch
  • BK Min
  • 승인 2023.05.09 14:42
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Irregular heart rhythm notification added to electrocardiogram monitoring, helping users seamlessly track abnormal heart rhythms

On the 9th, Samsung Electronics announced that the Irregular Heart Rhythm Notification (IHRN) feature of the Samsung Health Monitor app had received FDA clearance. With the app’s existing on-demand Electrocardiogram (ECG) function, the IHRN feature proactively monitors heart rhythms suggestive of atrial fibrillation (AFib) right from the wrist.

“We’re excited to announce that Irregular Heart Rhythm Notification, designed to help millions of people around the world who may not be aware of a potential heart risk, has been cleared by the FDA,” said Hon Pak, Vice President and Head of the Digital Health Team, MX Business at Samsung Electronics. “This is yet another example of how Samsung prioritizes proactive safety solutions and enables users to receive a more holistic understanding of their cardiovascular and overall health.”

Cardiovascular disease remains one of the world’s leading causes of death. AFib(a type of arrhythmia) is widely considered a warning sign for major cardiovascular issues that can increase the risk of stroke, heart failure, and other cardiovascular complications. Moreover, some AFib cases are asymptomatic or silent, leaving people unaware of their trouble.

That’s why Galaxy Watch offers tools to help users better understand their heart health using the Samsung BioActive Sensor, including on-demand ECG recording and HR Alert function that detects abnormally high or low heart rates. The new IHRN feature enables Galaxy Watch users to monitor another aspect of their health.

Once activated in the Samsung Health Monitor app, the feature will check for irregular heart rhythms in the background via Galaxy Watch’s BioActive Sensor. Suppose a certain number of consecutive measurements are uneven. In that case, Galaxy Watch warns the user of potential AFib activity, prompting them to take an ECG using their watch for a more accurate measurement.

The Irregular Heart Rhythm Notification feature will be available as part of the newly announced One UI Watch, coming first to the upcoming Galaxy Watch devices later this year and expanding to previous editions.


The summary of this article in Korean is as follows.

■美 FDA, 갤럭시 워치 불규칙 심장 리듬(IHRN) 기능 승인

삼성전자는 ‘삼성 헬스 모니터’ 앱의 ‘불규칙 심장 리듬 알림’ 기능이 미국 식품의약국(FDA)의 승인을 획득했다고 9일 밝혔다.

해당 기능은 하반기 출시되는 갤럭시 워치 신제품에 탑재된다. 이와 함께 소프트웨어 업데이트를 통해 기존 갤럭시 워치5와 워치4 시리즈에도 확대 적용될 예정이다.

갤럭시 워치에는 바이오 액티브 센서가 탑재돼 불규칙한 심박수가 감지되면 이를 이상 징후로 판단해 ‘심방세동’ 가능성이 있다는 알림 메시지를 워치 디스플레이를 통해 안내한다. 

삼성전자 MX사업부 디지털 헬스팀장 혼 팍(Hon Pak) 상무는 “미국 FDA 승인을 획득한 불규칙 심장 리듬 알림 기능은 심장 관련 위험 상황을 자각하지 못하는 사람들에게 큰 도움이 될 수 있다”며, “삼성전자는 고객의 건강을 지킬 수 있는 다양한 모니터링 기술 개발을 위해 지속 노력할 것”이라고 말했다.


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