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Apple Working With Health Canada to Bring Apple Watch Series 4's ECG Functionality to Canadian Market
Apple says it is working with Health Canada to bring the Apple Watch Series 4's all-new ECG functionality to the Canadian market, according to MobileSyrup's Patrick O'Rourke. No timeframe was specified.
This likely means that Apple has submitted an application with Health Canada for clearance to sell the Apple Watch Series 4 with the ECG functionality enabled. Health Canada has similar requirements as the FDA in the United States for medical devices to be sold in the country.
In the meantime, Apple says the ECG functionality will be limited to the United States, where it has received clearance from the FDA. However, the ECG app for watchOS 5 won't be available until later this year.
Apple Watch Series 4 models include a new electrical sensor on the rear that's designed to take an electrocardiogram using Apple's ECG app, the built-in sensor, and the electrode built into the Digital Crown. This allows the Watch to display a single-channel ECG, similar to a Lead I ECG, according to the FDA.
To take an ECG reading from the Apple Watch, users will need to place a finger on the Digital Crown while wearing the watch. The reading is completed in 30 seconds, allowing users to determine whether their hearts are beating in a regular pattern or if there are signs of atrial fibrillation.
As a potentially life-saving feature, Apple surely wants the ECG functionality to be available in as many countries as possible, so it's likely the company is working with public health agencies in other countries too.
Via: iPhone in Canada
This likely means that Apple has submitted an application with Health Canada for clearance to sell the Apple Watch Series 4 with the ECG functionality enabled. Health Canada has similar requirements as the FDA in the United States for medical devices to be sold in the country.
In the meantime, Apple says the ECG functionality will be limited to the United States, where it has received clearance from the FDA. However, the ECG app for watchOS 5 won't be available until later this year.
Apple Watch Series 4 models include a new electrical sensor on the rear that's designed to take an electrocardiogram using Apple's ECG app, the built-in sensor, and the electrode built into the Digital Crown. This allows the Watch to display a single-channel ECG, similar to a Lead I ECG, according to the FDA.
To take an ECG reading from the Apple Watch, users will need to place a finger on the Digital Crown while wearing the watch. The reading is completed in 30 seconds, allowing users to determine whether their hearts are beating in a regular pattern or if there are signs of atrial fibrillation.
As a potentially life-saving feature, Apple surely wants the ECG functionality to be available in as many countries as possible, so it's likely the company is working with public health agencies in other countries too.
Via: iPhone in Canada
Related Roundups: Apple Watch, watchOS 5
Buyer's Guide: Apple Watch (Buy Now)
[ 51 comments ]
Top Rated Comments
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4 weeks ago
Why can't they just enable it with a disclaimer "This is not legally a medical device." in the countries where it doesn't have approval as a medical device?
4 weeks ago
If people are interested, you can follow new Health Canada device approvals at the following RSS feed:
https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/rss/dhp-mps/devices-instruments-eng.xml
https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/rss/dhp-mps/devices-instruments-eng.xml
4 weeks ago
I
I doubt UK (NHS) will sign up for this in a hurry, but I personally would welcome it. Take up of AW4 could be more subdued in countries were this key feature is not implemented.
4 weeks ago
Don't think it's anything to do with the NHS - Apple will be trying to get EU approval at which point it will have been approved throughout the EU.
Which had better happen before the end of March 2019 or it will be down to the useless UK government who will debate it for 20 years.
4 weeks ago
in my honest opinion, there are significant downsides to having too much insight into one's physical health.
Perfect toy for hypochondriacs
4 weeks ago
I
I’ll be trying the region trick as soon as it appears in the developer beta (UK)
I doubt UK (NHS) will sign up for this in a hurry, but I personally would welcome it. Take up of AW4 could be more subdued in countries were this key feature is not implemented.
4 weeks ago
Don't think it's anything to do with the NHS - Apple will be trying to get EU approval at which point it will have been approved throughout the EU.
If so, they better hurry up and do it before March 19.
4 weeks ago
True! And at 67 my heart will have stopped responding before the 20 years is up :))
Glass of red wine every evening and some light cardio exercise (and a sprinkling of genetic luck) may well see you to 100 ;)
4 weeks ago
I’ll be trying the region trick as soon as it appears in the developer beta (UK)
4 weeks ago
Which had better happen before the end of March 2019 or it will be down to the useless UK government who will debate it for 20 years.
True! And at 67 my heart will have stopped responding before the 20 years is up :-))[ Read All Comments ]
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