Apple has made available in Australia its electrocardiogram app for Series 4, 5 and 6 of its Apple Watch. An irregular rhythm notification feature that checks atrial fibrillation was also included in the Apple Watch Series 3 and later versions.

WHAT IT DOES

An Apple Watch with the A-Fib feature uses an optical heart sensor to occasionally check a user's heart rhythm. It alerts the user with a notification if an irregular rhythm is detected on five rhythm checks over a minimum of 65 minutes.

According to a statement on the Apple website, after 30 seconds, the ECG app can classify a user's heart rhythm as either A-Fib, A-Fib with high heart rate, sinus rhythm, low or high heart rate, inconclusive, or poor recording. Records are safely secured in the iPhone Health app and can be shared with doctors in PDF format.

Based on Apple's clinical trial of around 600 participants, the ECG app has demonstrated 99.3% specificity in classifying sinus rhythm and 98.5% sensitivity in classifying A-Fib.

The tech giant has also tested its irregular rhythm notification feature on over 400,000 participants, the results of which were included in the Apple Heart Study published in 2019. In December, the US FDA cleared Apple's A-Fib update on the ECG app.

WHY IT MATTERS

The ECG app, along with its irregular rhythm notification feature, can help users identify signs of A-Fib, the most common form of irregular heart rhythm that can lead to stroke.

“Data collected by Apple Watch could be used to help diagnose atrial fibrillation early,” said Bill Stavreski, general manager for Heart Health and Research at the Australian Heart Foundation.

In a statement, Stavreski said many people may not show symptoms or ignore the occasional symptoms of A-Fib. "This means the problem might not be found until serious consequences, such as a stroke, occur, so early diagnosis can lead to a better outcome," he added.

Both the ECG app and the A-Fib notification feature were included in the Australian Register of Therapeutic Goods as Class IIa medical devices.

MARKET SNAPSHOT

Apple was the first to launch an ECG app in 2018. Since then, it has drawn competition with Samsung, Fitbit and AliveCor.

In April, AliveCor accused Apple of infringing on its patented technology, including the ability to take ECG readings on the Apple Watch. It filed a complaint with the U.S. International Trade Commission, seeking to ban the sales of Apple Watches. Meanwhile, AliveCor has updated its ECG devices to identify three more heart conditions.  

After getting its Health Monitor app cleared for commercialisation in Europe, Samsung announced in January the expansion of its ECG smartwatch tool, along with a blood pressure feature, to 31 countries.

Fitbit was the latest to launch an ECG app on its wearable devices in August last year.

ON THE RECORD

"Apple Watch has helped so many people around the world, and we are humbled that it has become such an important part of our customers’ lives. With the release of these heart features, Apple Watch takes the next step in empowering people with more information about their health," Apple COO Jeff Williams said in a statement.

"We are confident in the ability of these features to help users have more informed conversations with their physicians. With the ECG app and irregular rhythm notification feature, customers will be able to better understand aspects of their heart health in a more meaningful way," said Apple's VP for Health Sumbul Desai.