Apple Watch Irregular Heart Rhythm Notifications Approved in Australia as ECG Approval Edges Closer
The Apple Watch's irregular heart rhythm notifications have been approved in Australia, indicating that approval for the ECG feature may be soon to follow after years of waiting, according to EFTM.

Documents seen by EFTM from Australia's Therapeutic Goods Administration show that the Apple Watch's irregular rhythm notifications feature has now been approved and added to the Australian Register of Therapeutic Goods. While this does not mean that the ECG function has been medically certified for use in Australia, it concretely proves that Apple has begun submitting its devices and software to Australian regulatory authorities for approval.
The irregular rhythm notification feature intermittently checks heart rhythm in the background and sends a notification if an irregular heart rhythm is identified that could potentially be atrial fibrillation (AFib). Upon receiving a notification, users in territories where the feature is approved can immediately launch the ECG app and perform a more comprehensive test in just 30 seconds by placing their finger on the Digital Crown to generate an ECG waveform. The irregular rhythm notifications and ECG feature therefore work hand in hand, so it seems unlikely that one feature will be approved long before the other.
Atrial fibrillation is a health condition that often goes undiagnosed, so ECG app and heart rhythm alerts on Apple Watch are highly useful for detecting early signs of disease. ECG readings also normally require a full ECG machine and a visit to the doctor, which is far less convenient than a reading taken with the Apple Watch.
Apple routinely has to gain approval from government health agencies before making the Apple Watch's ECG feature available in different countries. Apple won U.S. FDA clearance to promote and launch the function when the Apple Watch Series 4 was released in 2018. Over two years later, the feature is still not available in Australia.
Last year, the Withings ScanWatch, which similarly features the ability to take an ECG, was approved in Australia, so it is not clear why it is taking Apple so long to apply or gain approval. Regardless, the irregular rhythm notifications approval is the strongest indication yet that the ECG feature is finally edging toward regulatory assent in Australia.
Popular Stories
As previously rumored, the next-generation iPhone 15 Pro and iPhone 15 Pro Max will feature a unified volume button and a mute button, according to leaked CAD images shared in a video on the Chinese version of TikTok and posted to Twitter by ShrimpApplePro.
Instead of separate buttons for volume up and volume down, the iPhone 15 Pro models are expected to have a single elongated button for...
A first-generation iPhone still sealed inside its box sold for $54,904 at auction, which is more than $54,000 over the original $599 price tag of the device when it was released in 2007.
The original iPhone was put up for sale by RR Auction on behalf of a former Apple employee who purchased it back when it first came out. Back in February, an original, sealed iPhone sold for over $63,000,...
While year-over-year iPhone upgrades are not always groundbreaking, new features can begin to stack up over multiple generations. For example, the iPhone 15 Pro will be a notable upgrade for those who still have a three-year-old iPhone 12 Pro.
If you are still using an iPhone 12 Pro and are considering upgrading to the iPhone 15 Pro when it launches later this year, we have put together a...
Apple's high-end iPhone models have started at $999 in the U.S. since they first launched back in 2017 with the iPhone X, but could this finally be the year that starting price sees an increase?
This week also saw some more rumors about Apple's upcoming headset and the company's explorations in the booming AI industry as well as the release of a new round of beta updates, so read on for all...
The iPhone 15 Pro Max will have the thinnest bezels of any smartphone, beating the record currently held by the Xiaomi 13. That's according to the leaker known as "Ice Universe," who has divulged accurate information about Apple's plans in the past.
Both iPhone 15 Pro models are expected to have thinner, curved bezels compared to the iPhone 14 Pro, potentially resulting in an Apple...
While the iPhone 15 lineup is around six months away, there have already been plenty of rumors about the devices. Many new features and changes are expected for the iPhone 15 Pro models in particular, including a titanium frame and more.
Below, we have recapped 11 features rumored for iPhone 15 Pro models that are not expected to be available on the standard iPhone 15 and iPhone 15 Plus:A17...
Apple continues to test iOS 16.4, which includes a handful of new features and changes for the iPhone. Below, we have recapped five new features coming with the software update, including new emoji, push notifications from websites, and more.
Apple says iOS 16.4 will be available in the spring, which begins today. In his newsletter this weekend, Bloomberg's Mark Gurman said the update should ...
Top Rated Comments
TGA delayed their changes that would allow ECG on a smartwatch to get approved from July 2020 to February 25 2021. So the Apple watch ECG feature literally can’t get approved before that date.
Link so you can read the changes: https://www.tga.gov.au/medical-devices-reforms-medical-device-software-regulation
Apple is probably one of the companies that was lobbying for these changes. No need to blame TGA’s problems and delays on Apple.
people go to the doctors and have tests done all the time to eliminate suspected problems.
never look at any of the exercise/health functions on your watch? no sleep pattern stats?
it's all data.
use it or dont.
but if the sensors are there and being used to save lives overseas then why can't we have the same functions here?