Apple Watch: ECG In Australia

Ok, it’s now 04 July 2020.

So, when will ECG be released in Australia.

I upgraded my Apple Watch specifically to get ECG, promised by Apple at that time.

Who is responsible in the Medical profession here for this absurd level of procrastination, please tell me...

Apple Watch

Posted on Jul 3, 2020 5:16 PM

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Posted on Feb 3, 2021 11:43 AM

Given the registration hasn't occurred the issue is hardly solved!

Interesting that Apple doesn't seem to be able to negotiate the relatively easy TGA registration process, especially since there exists what is known as a Global Medical Device Nomenclature code (recognised by the TGA) that covers the hardware and another that covers the software! Would hate to think it is just laziness on Apple's part or that they won't provide any details to TGA, which to be frank is usually less than the US and the same as the UK and EU.


For information, the relevant codes are below. Registration takes less than a day to complete the form and usually an answer is received within a couple of days.

Hardware

Name

Wearable multiple physiological parameter recorder

Definition

An electrically-powered, wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiograph, haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a local application (e.g., smartphone) or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns).


Software


Name

Smartphone camera home cardiovascular monitoring application software


Definition


A software program designed for use in a smartphone/watch with a built-in camera to periodically measure, via transcutaneous optical reading, and display cardiovascular parameters (e.g., pulse wave, heart rate variability, SpO2, blood pressure, LVEDP) for assessment of cardiovascular function to assist diagnosis of disease (e.g., arrythmia, cardiac autonomic neuropathy); it may also be used to provide general lifestyle/fitness advice or during a controlled Valsalva manoeuvre to facilitate cardioversion of supraventricular tachycardia (SVT). This is a home-use device which may allow for remote communication of data with a clinician; it may in addition be used in a clinical setting.

425 replies

Sep 26, 2020 11:03 PM in response to IdrisSeabright

In Australia we use other ways measure an ECG. Basically you wait until one side of your body is numb and in paralysis. Then you book in with your doctor get a referral to get an ECG. Wait 2-3weeks and then see a specialist. In New Zealand, UK and USA they have a far inferior system where your apple watch may catch issues before you you realise there is an issue.

Oct 7, 2020 7:56 PM in response to Dimov4

I too are like everyone else..


Paid good money for this watch expecting to have the ECG function, and expecting that, Apple being a trillion dollar company would have more clout to have things changed here in Australia to have the ECG function enabled.

I am in my 60's and similar to other comments, I too purchased the watch not only for the fantastic features, but also for my Heart Health and the ECG function.


Come on guys... get this feature happening so I can finally get what I paid for.


Craig.


Oct 31, 2020 1:18 PM in response to SamoAt18

I'm guessing that you are new to the world of Apple.


In the 36 years that I've been using Apple products, Apple has never done what you are wishing it to do!


If you believe that you were mislead by an Apple retail employee in Australia, then the best way to resolve that is to go directly to that store's manager, not complaining on a US-based user to user support forum.

Oct 31, 2020 7:27 PM in response to SamoAt18

If you say so, I wasn't clear, it's perhaps your 1st language. You, however are the 1st to have said so.


And I'm just sooooo ashamed for enjoying posting here. You've really put me in my place.

I posted to ask for help on where to go to find out when Apple expected Australian approval.

The folks posting here are volunteer users of Apple products. No one here would have the answer to that question. Not deggie, not Idris, not Stanley and not me. Apple doesn't reveal its product or business plans to folks here; to folks seeking help nor folks offering help.

Nov 3, 2020 1:23 PM in response to Joseph from Australia

And...”Withings says 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.”


I have two friends who have discovered, late, that they have arterial fibrillation, in one case necessitating emergency hospitalisation, so I have more than a techie interest in this. While there’s no guarantee that any of these devices are 100% accurate Apple’s own research data makes the point that among their test subjects, notwithstanding false positives, there were a significant number of cases of the watch alerting the wearer to an underlying, undetected and potentially fatal heart condition. That’s the whole point of developing such a feature.


So we have heart disease as the leading cause of death in Australia and no access to a device that could save lives and is actively marketed as that overseas. The Withing’s experience suggests the problem is not with the TGA. I’m done with this forum and will buy a Withings watch and recommend them to all...


It’s bad for your brand when you disappoint customers, but it’s fatal when you make them angry.


Nov 17, 2020 5:38 PM in response to SamoAt18

What standards? And I didn't bring up the Withings.


But since it is approved why don't you talk to Apple Customer Service, return your Apple Watch for a refund and then buy the Withings? Problem solved. And maybe Apple should follow Withings lead and only sell the Apple Watch Series 3 in Australia. Would this be a reasonable solution for you?

Nov 17, 2020 5:56 PM in response to Robert J McInnes

Joseph of Australia (in a deleted comment) said -
a few times when I have told the truth on other pages, a level higher with administration rights deletes my facts.

Just so you lot know, none of us in the Apple Support Communities has Admin rights. The only folks doing any deleting are the Apple Support Communities Hosts, who moderate the threads.


However, anyone who is Level 2 or higher can report a comment to the Apple Support Communities Hosts who will then take a look at the comment and edit or delete as they see fit. You will find the Report facility in the down arrow menu under every comment.

Nov 17, 2020 5:52 PM in response to deggie

I stand (actually I'm sitting) corrected. It was a long, long, long time ago, ♫ south of the border, down Mexico way ♫ that I became a Level 2. I don't recall the perks of that great achievement.


Yes, new I remember, when you become a Level 6 you get the top secret Apple Decoder Ring! And access to the booze in the Water Cooler in the Lounge.

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Apple Watch: ECG In Australia

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