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BlinkyBill
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  #2414845 9-Feb-2020 07:35
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jonherries: To be clear, these regulations from 2003 (not 2013) aren't very useful because they don't provide useful descriptions of what a medical device is, particularly in the context of software and more interestingly 3D bio-printing and genomics (like Car-T Cell therapy), this is a fundamental issue and a large part of the reason for developing new legislation. You can read more here about some of these issues here (there are more issues than are listed here):

https://www.pharmac.govt.nz/hospital-devices/fairer-access-to-hospital-medical-devices/

This is also useful to read in this context (the definition of what a medical device is according to the regulations):

http://www.legislation.govt.nz/regulation/public/2003/0325/latest/DLM224296.html#DLM224296

Secondly and maybe more importantly, which it appears Apple and @BlinkyBill have failed to realise is this is a registration only, not an approval.

Jon

 

Thanks; sorry about the typo.

 

it’s interesting ... I had thought, I guess assumed, that medical devices needed to be approved for use. Given the possible negative affects of over-medicalising a  medical event, a possible AFib, to me it makes sense that a medical device should only be used when it is shown to me medically safe and medically useful, which are two different things.

 

I’m going to start selling my Robodoc2000 immediately - no need for trials or evidence that it works.

 

I’m having breakfast with Bloomers in a couple of weeks - it’ll be interesting to see what he says.




idle
175 posts

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  #2414938 9-Feb-2020 10:57

It should be noted that these ECG devices are only useful in assisting diagnoses of abnormalities of heart rate, such as tachycardia (rapid heart rate), bradycardia (slow heart rate) and atrial fibrillation (irregular heart rate). They are not helpful in episodes of possible angina, nor in possible myocardial infarction. These require a full 12 lead ECG in hospital or doctors consulting rooms. In addition it should be pointed out that the diagnosis of heart rate abnormalities is only made by a doctor on receipt of .pdf file of the ECG.  The devices are fairly new, and it may be, in time, that they will be developed to deal with other heart problems and, eventually, give you a diagnosis on a print out. I would suggest that more supervision from our legislators may be necessary if the ROBODOC comes to pass!


corksta
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  #2441122 19-Mar-2020 10:55
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Looking at the release notes of the GM build of watchOS 6.2, when it releases to the public next week we’re getting the ECG app as well as irregular heart rhythm notifications. 





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Shoes2468
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  #2441161 19-Mar-2020 11:34
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corksta:

 

Looking at the release notes of the GM build of watchOS 6.2, when it releases to the public next week we’re getting the ECG app as well as irregular heart rhythm notifications. 

 

 

 

 

Sure looks that way according to this imore article.

 

https://www.imore.com/apple-watch-users-new-zealand-chile-and-turkey-are-getting-ecg-support-next-week

 

 


michaelmurfy
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  #2441163 19-Mar-2020 11:35
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corksta:

 

Looking at the release notes of the GM build of watchOS 6.2, when it releases to the public next week we’re getting the ECG app as well as irregular heart rhythm notifications.

 

I'm loading this now on my iPhone and Apple Watch as a test. Your iPhone needs to be on 13.4 before your Apple Watch can be upgraded to 6.2.





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michaelmurfy
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  #2441237 19-Mar-2020 13:55
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And Confirmed. I've now got ECG on my Apple Watch Series 5 running 6.2!





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grenow
37 posts

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  #2441238 19-Mar-2020 14:00
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Here's the link to the Apple news announcement, as tweeted by Peter Griffin this morning.


 
 
 
 

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hrishter
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  #2441536 19-Mar-2020 17:36
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michaelmurfy:

 

And Confirmed. I've now got ECG on my Apple Watch Series 5 running 6.2!

 

 

Did you just install the beta profiles and update your watch and iPhone? I updated mine earlier today, but no luck with the ECG app?


firefuze
510 posts

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  #2441653 19-Mar-2020 19:32
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Have it running on my Watch. The ECG App is not installed on the watch by default. Once updated you need to launch ECG from within the Health app on iPhone where it will then prompt you to install the ECG app to the Watch

TwoSeven
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  #2441686 19-Mar-2020 20:23
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Got the ios update but watch update according to the article appears to be next week





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TheoM
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  #2441790 20-Mar-2020 01:36
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TwoSeven:

 

Got the ios update but watch update according to the article appears to be next week

 

 

Got both updates via beta profiles. Once that's done you need to remove the profiles from both your watch and iPhone, then restart both. Once done you should be able to enable ECG





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canuck
18 posts

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  #2446058 25-Mar-2020 10:01
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Apple Watch ECG for NZ was enabled today. iOS may also need to be on latest version (13.4) that was also released today.

 

https://www.macrumors.com/2020/03/24/apple-releases-watchos-6-2/


Benjip
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  #2446061 25-Mar-2020 10:07
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I just did my very first ECG and am pleased that all seems normal.

 

Very cool how it walks you through the set up process. I happened to move my left arm the first time and it reset the 30-second counter and told me to stop moving.


  #2446462 25-Mar-2020 16:27
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Yup all setup on mine, Yay that we have it now its pretty cool. 





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Lumenz
7 posts

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  #2446651 25-Mar-2020 20:34
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It just arrived in NZ (but not Australia) with Watch OS 6.2!!

 

Apple Watch ECG now available in New Zealand!


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