Samsung Electronics announced that the irregular heart rhythm notification feature of its health monitor app received FDA clearance.
Combined with the app’s existing on-demand ECG function, the feature proactively monitors heart rhythms suggestive of AFib. It all works straight from the user’s wrist through the Samsung Galaxy Watch.
“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, VP 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.”
Galaxy Watch utilizes the Samsung BioActive sensor. It includes on-demand ECG recording and heart rhythm alert functions that detect abnormally high or low heart rates. Adding the irregular rhythm notification enables users to monitor another aspect of heart health.
Once activated, the feature checks for irregular heart rhythms in the background. If it registers a certain number of irregular consecutive measurements, Galaxy Watch warns the user of potential AFib activity. This prompts them to take an ECG using their watch for a more accurate measurement.
The new notification comes as part of Samsung’s newly announced One UI5 Watch. It will come to upcoming Galaxy Watch devices later this year before eventually expanding to previous editions.
Samsung is the latest to bring AFib detection to a smart watch
The competition around using smart watches to track health continues to heat up. Samsung’s FDA clearance marks the latest addition to the space.
Masimo and AliveCor are two companies that develop their own health-monitoring watches. Both companies are involved in litigation with Apple, which added health monitoring to its popular Apple Watch. Most recently, there was a mistrial in Masimo’s smartwatch trade secret spat with Apple over pulse oximetry capabilities.
On the company’s first-quarter earnings call, CEO Joe Kiani said the company’s legal costs total $55 million and counting in this battle. The spat includes five separate cases.
“In life, you don’t get many do-overs,” Kiani said. “We’re going to get [a] do-over, so we will be retrying this case and hopefully — given how good the case came and how everyone assumed it would go — we expect next time we’ll get very different results.”
The U.S. International Trade Commission must now consider whether to implement an import ban on Apple Watches.
A similar spat over IP went on between AliveCor and Apple. It ended in February when the final determination rule favoring AliveCor cleared presidential review.