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
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.
The new algorithm doesn't have anything to do with the ECG hardware, it allows checking for afib at higher heart rates. The TGA regulations cover the hardware used for ECG, not particularly the software. Nothing has changed in how ECGs are taken.
There's another chapter in that Aussie tale of fiction that you've been weaving.
At least go back 4 or 5 pages and read the comments before spouting off things about which you know nothing. It was established, by deggie himself I believe, that the Aussie TGA was changing the regulations in FEB 2021.
Why don't you know these things?!?! You must do your research if you wish to publish a book based on facts. We've had a guy here in the US who spouted off a lot the past four years, he rarely told the truth.
miloks wrote:
At the very least, our should be made clearer that these features aren’t available on the website
You mean like this?
To the best of my knowledge, Apple did not promote ECG in Australia. If you are reading web pages in other countries, or watching U.S. based keynotes, that is not something Apple can control.
You honestly think Apple doesn't know how to do this and has not conferred with the TGA? What Apple does know is under the current guidelines their ECG function would not be approved.
Having dealt with the TGA, I don't think the problem is them but Apple. Registering as a Class 1 Medical Device is neither difficult or time consuming.
Thanks for asking about the new ECG feature.
Check here for availability in your region: ECG
ECG requires the current non-beta version of iOS and watchOS. For additional help with the ECG feature on your Apple Watch, take a look at these articles.
Heart rate notifications on your Apple Watch - Apple Support
Taking an ECG with the ECG app on Apple Watch Series 4 or later - Apple Support
If you have any other questions please reach out to our team here: https://apple.co/HeartFeatures. If you believe that you are experiencing a medical emergency, please dial your local emergency services.
Take care
According to the TGA, Apple has not taken this step. However, Apple has not said why.
And that's the end of it. When we created our accounts here, we agreed not to question Apple's product and business decisions.
At this point it's time for you to accept the current situation and move along. There isn't anything more to discuss.
Asked and answered.
I'm a long time user (1984) of Apple products, like most everyone else who posts in the Apple Support Communities. I am NOT an Apple employee or representative in any fashion.
Expecting things to just work, doesn't apply to functions and features that are illegal in any specific country; such as the Watch ECG function in a number of nations across the world and the iPhone's FaceTime function in certain Middle Eastern countries.
No one here considers you and uneducated imbecile, that is just you thinking that. All Apple products work as advertised in the parameters allowed by the countries they are sold in. And as Dah*veed said most everyone on the forums doesn't work for Apple and we just try to help where we can. Yelling at us for something your Government restricts doesn't help anything.
I recently had an atrial flutter conditipon diagnosed and had atrial ablation surgery to help fix it. It was successful in stopping the flutter but now have sporadic atrial fibrillation events. I now feel much healthier than before but still not perfectly clear.
My watch was telling me when my pulse was over 100 bpm at rest but foolishly I ignored it. I actually dismissed the warnings thinking that the technology could not be trusted. Then looking at the recorded trends in the Health app, I can see that this has been going on for over 18 months. If I had paid more attention to what the watch was monitoring, I may have referred this to my doctor some time back.
Now after the treatment, I regularly refer to the health app to monitor my heart rate. It's interesting that the heart rate variation is a major indicator of the fibrillation problem that I now have. I would be extremely dissapointed if Apple downgrade the facility in watchOS 7.
How crazy is it that the ECG function is not enabled in Australia. AN ECG is a primary indicator of a heart anomaly. I would have had no problem "seeing" that a irregular waveform indicates something is wrong. I went out and purchased an Alivecor ECG monitoring device to observe my ECG. Frankly it is little more than the Apple ECG app. How is it that Alivecor can can registration in Australia yet apple can't?
With the Alivecor, I need to find it, open the iphone app and place my thumbs either sisde of the device. It takes a 30 second recording. It's ridiculous that virtually the same technology already exist on my watch but I can't use it!
Maybe it's Apple who have not applied for approval or maybe the government agency? Maybe the AMA is holding things up. I was lucky to have found my life threatening condition by a chance visit to the doctor. It was picked up by low blood pressure and an ECG while I was having an actual heart flutter event.
Wake up Apple and the Australian goverment. You have an opportunity to save lives. Someone has their head buried up there arse on this.
if You’re not in Australia, then please don’t comment on our political system or our rules. The TGA have issued statements saying they have not received an application from Apple.
My dispute with this thread is that the response marked as the “answer” to the initial question should not be considered the answer. It is a politically charged and incorrect post that does not provide a solution in this instance.
The buck stops with Apple. Customers should not have to trawl through discussions to get an answer to two simple questions. Have you applied to the TGA? What sort of timing do you see on approval.?
The buck stops with Apple.
miloks wrote:
Yes - in store staff. The staff in physical brick and mortar stores.
Alright, that I can help you. Report them to the supervisor.
EDIT: Correction, ECG is not advertised, not blood pressure. I will have a moderator edit my previous post.
A personal device is never going to replace what is used in clinics as demonstrated overseas. Samsung, apple or Garmin.
one group opposing its introduction is based that you will get more false positives. This is true. But you will also get more real cases also. As people will have an awareness of what their own body is doing. My resent tests from the health System here in Australia is a prime example of duplication and money wastage to the highest degree. Given the modern propensity for people google their symptoms and medication ask medical professionals questions this is a good thing. If they can’t tell you why you need certain tests or explain the risks then maybe they aren’t meeting minimal standards either.
Apple Watch: ECG In Australia
