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.
I don't know what advertising is played in Australia. How much extra did you pay for the ECG and heart alerts. Maybe Apple could refund that money.
There was a post in this thread that listed the changes. Look for it. Apple will never release such information, they don’t work that way and they don’t know.
Apple isn't likely going to apply unless they're certain it's going to be approved, as mentioned before.
Several years in with no approved ECG, TGA’s stance and that of Apple’s is quite obvious.
I’ve noticed there is now another watch with ECG features available in Australia. The Withings ScanWatch. I’m seriously considering ditching the Apple Watch and buying one.
You are still missing the point: Apple has not stepped up to the line to let loyal users know the progress on Australian approval for the ECG function in the Apple Watch.
That’s not technically right Bob. Do you live in Australia? If not butt out! TGA changes it’s laws just over 2 years ago. Apple has been sulking and sitting in its hands ever since. They play god.
Australia should be able to sort this out with Apple.
I understand the strict rules set by Australian authorities there should be some guidance or plan to be able to move forward. We can’t just give up and say “oh well Australia has strict laws”.
if it approved in many other countries then why can’t it be approved here.
Even if it’s classed as a Medical device.
Something needs to be done. Australia or Apple needs to make this happen. Why Australians miss out on this feature is ludicrous
I must agree with this string, I to purchased an Apple Watch primarily for the ECG function as I had seen it used overseas, at the time the Apple representative at the Apple Shop told me it should all be sorted by the end of the year (2019)!
Now it is time to decide to stick with Apple or move across to Android as we obviously don’t matter to Apple in Australia.
Very disappointing as we have always been big supporters of Apple
Do you honestly think that Apple is the holdup here? If that is the case why have they been getting it approved in a number of countries across the globe? And don’t buy the “they haven’t applied” argument, that isn’t the way it works.
@Blugle,
You use your first post here to claim that you are a long time Apple "supporter" and to threaten to pull up stakes and move to Android? Kindly tell us which Android watch approved for use in Australia has a built-in ECG device on par with the Apple watch.
Apple have done a few things recently that have disappointed me including a couple of updates that seem to cause more problems than good.
They also push "do it our way or go elsewhere" I understand that this is one of the reasons they have been successful as more less technical people can use the products however the inflexibility can get frustrating at times.
My only hope is that someone at Apple follow these Posts and try to get the ECG situation sorted, as stated by my previous Post, our market is so small compared to other parts of the world and often don't seem to get the support we would like to see.
I have purchased a small ECG unit called a Kardia that works with an App on my iPhone, maybe Apple could see how that is allowed to be sold in Australia!
OK, by reading your replies, I will just need to understand and appreciate that I am another one of the uneducated imbeciles that currently use Apple products and just expect things to work.
Don't bother replying, I just hope that you are not a representative of Apple or maybe you are and this is their attitude to there customers.
If the Australian Gov law is too hard to get around Apple should change the name from ECG to Heart Rate Monitor Plus...Simple! Australian Gov left out of the loop...Australian public have a awesome heart rate Monitor
Apple Watch: ECG In Australia
