Samsung recently announced that it got FDA clearance for irregular heart rhythm notifications. The company’s watches already have an electrocardiogram (ECG/EKG) monitoring function, and the new feature will roll out later this year.
The fact that watches can track your heart rate is no longer a novelty, but increasingly, the time-keeping tools we carry on our wrists do more than just keep time. For instance, some watches already have on-demand ECG recording and alert functions that let you know when something is off with your heart rate. Now, several companies are looking at the next thing: arrhythmia.
A heart arrhythmia is essentially an irregular heartbeat. It’s not like when you exercise and the rate goes up, or when you relax and it goes down. It happens when something is off with your heart rhythm. Frequent irregular rhythm may indicate that your heart is not pumping enough blood to your body and could cause serious problems in time. They can lead to stroke, heart failure, or cardiac arrest.
“Cardiovascular disease remains one of the world’s leading causes of death, and 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,” writes Samsung in a press release. “Moreover, some of AFib cases are asymptomatic or even silent, leaving people unaware of their risk.”
Arrhythmias are treatable with medicine or procedures — but detecting them isn’t easy, and figuring out whether they happen regularly is even harder. That’s where watches come in.
We carry our watches around all day, so if they could look for things like arrhythmias, you’d be essentially having a monitor with you. You don’t need to do anything: once the feature is enabled, the watch will monitor for irregular heart rhythm in the background and alert users once a threshold of irregularity is reached. Then, you’ll be prompted to take an electrocardiogram.
“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.”
Samsung isn’t the only company looking at this. The FDA also granted approval for Fitbit’s passive AFib monitoring feature recently. However, although watches are gaining more and more smart functions that can help keep us healthy, it’s important to keep in mind that they are not specialized medical equipment.
In fact, Samsung specifically emphasizes that the feature is “not intended to provide a notification on every episode of irregular rhythm suggestive of AFib” and that “the absence of a notification is not intended to indicate no disease process is present”. The feature is also not aimed at users who have known arrhythmias or are aged 21 or less. It strictly aimed as an early-warning tool.
“ECG app is not intended to replace traditional methods of diagnosis or treatment,” writes Samsung. “Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.”
“The HR Alert function is for general health and wellness purposes and is not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease.”
Still, while it’s crucial to keep in mind that these aren’t specialized medical devices, it’s pretty remarkable just how much health and wellness information fitness trackers can provide nowadays. This advent of wearable smart tech works hand in hand with personalized medicine, and these signals could be used to inform medical practitioners and provide early alerts for a number of health issues. However, some experts see this as yet another frontier for privacy breaches, where companies can have access to personalized data that they can then use for other purposes. Data collected by a fitness app is not protected like health information under the law, at least in most countries.
The Samsung feature will first become available on the new UI update. It will roll out first to the upcoming Galaxy Watch devices later this year, and then to devices sold previously.