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.

apple watch ecg wrist

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.

Related Roundup: Apple Watch Series 6
Tags: Australia, ECG
Buyer's Guide: Apple Watch (Caution)
Related Forum: Apple Watch

Top Rated Comments

bobmans Avatar
19 weeks ago

When did Apple submit it for approval?
Why would they bother submitting if it would get denied? That’s like applying for a CEO position when you’re a 16-year old highschooler.

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.
Score: 11 Votes (Like | Disagree)
wbeasley Avatar
19 weeks ago

I wouldn’t be surprised if the Apple Watch is never approved as an ECG in Australia. The reports of false positives and concern it would cause a rise in unnecessary doctor visits and tests would be enough to stop it.
better a false positive than say dying.

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?
Score: 8 Votes (Like | Disagree)
bobob Avatar
19 weeks ago
The hold up is on the Australian end, not Apple's.
Score: 7 Votes (Like | Disagree)
-BigMac- Avatar
19 weeks ago
HELL YEH! About time. Now for ECG :)
Score: 7 Votes (Like | Disagree)
Stephen.R Avatar
19 weeks ago

I predict 2050 before they ever get a car off the ground
I dunno man, 30 years for a hover car seems pretty good to me.
Score: 4 Votes (Like | Disagree)
Boeingfan Avatar
19 weeks ago

Why would they bother submitting if it would get denied? That’s like applying for a CEO position when you’re a 16-year old highschooler.

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.
Thank you for the link. I, like many others, have been looking forward to this feature, and by you providing the link I was able to read some factual information about what's happening from the TGA end. Cheers.
Score: 3 Votes (Like | Disagree)

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