Apple Watch in hearty approval

It’s taken time, but Apple has ­finally received Australian medical approval for one of its Apple Watch heart-monitoring functions.

Apple Watch atrial fibrillation notification

It’s taken time, but Apple has ­finally received Australian medical approval for one of its Apple Watch heart-monitoring functions — more than two years after approval was obtained from the US Food and Drug Administration for the same feature in the US.

The Silicon Valley giant has been facing pressure to have its electrocardiogram (ECG) and ­irregular rhythm notification features approved by the Therapeutic Goods Administration in Australia.

Despite Apple Watch being seen as offering medical support in monitoring heart irregularities, Apple had not enabled these functions in Australia because the company had not sought or obtained local clearance.

Finally the first of these, the irregular rhythm notification feature, has been approved.

A TGA notice dated February 2 said the feature had been added to the TGA’s register.

“The feature analyses pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation [AFib] and provides a notification to the user,” the notice said.

“It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis.”

Apple Watch atrial fibrillation notification

Apple has taken a long time to obtain Australian approval. The feature has already been approved in Japan, Thailand, Taiwan, Colombia, Israel, United Arab Emirates, Brazil, Saudi Arabia, New Zealand, Chile and Turkey.

At its 2018 launch, Apple chief operating officer Jeff Williams said the company was “working hard to bring [ECG and irregular rhythm notification features] to customers around the world”.

TGA approval of the ECG function is likely given its ­approval in other countries.

Apple has also been under pressure to obtain these approvals and keep that 2018 promise.

In Australia, Apple faced competition from other watch makers such as French manufacturer Withings, which last year obtained TGA approval for its ECG and AFib (irregular heart rate) capabilities on its ScanWatch.

Withings had said its TGA approval only took “a couple of weeks” as it was able to send the same performance information to it as it did to authorities in other countries. This statement had raised further questions as to why Apple was taking so long in Australia.

The TGA notice said Apple’s irregular rhythm notification feature was not intended for use in people under 22 as testing of this group had not taken place. It was also not intended for people previously diagnosed with AFib.

It will require a software update to Apple Watch’s operating system for any of this functionality to be actively available.