Health Canada Gives Green Light to ECG App on Apple Watch

[MacRumors]

Health Canada has cleared the ECG app and irregular heart rhythm notifications on the Apple Watch Series 4, suggesting that both features will make their much-anticipated debut in Canada in the near future.

As spotted by the blog iPhone in Canada and confirmed by MacRumors, Health Canada issued active licenses for both features on May 16. The regulatory agency classifies the Apple Watch Series 4 as a Class II medical device, placing it in a "low-to-medium risk" category alongside the likes of contact lenses.

To view the licenses, navigate to the Health Canada search page and search for Apple based on company name.

The ECG app first launched in the United States last December as part of watchOS 5.1.2. The feature expanded to 19 European countries and Hong Kong in watchOS 5.2 in March and to five more European countries in watchOS 5.2.1 last week.

With clearance from Health Canada, Apple could expand the ECG app to Canada in either watchOS 5.3 or watchOS 6, the latter of which should be unveiled at Apple's annual Worldwide Developers Conference next month.

Apple Watch Series 4 users can generate an ECG waveform in just 30 seconds by placing their finger on the Digital Crown.

Electrodes built into the Digital Crown and the back crystal work together with the ECG app to read your heart's electrical signals. Simply touch the Digital Crown to generate an ECG waveform in just 30 seconds. The ECG app can indicate whether your heart rhythm shows signs of atrial fibrillation -- a serious form of irregular heart rhythm -- or sinus rhythm, which means your heart is beating in a normal pattern.

Apple has yet to mention the ECG functionality on the Apple Watch health and fitness page on its Canadian website.

Article Link: Health Canada Gives Green Light to ECG App on Apple Watch

 

[bchery21]

Oh boy, the wait is almost over Canada!

 

[davidec]

Cmon Aussie. Surely we’re soon too. Good work Canucks.

 

[Rodney Dangerfield]

Fantastic News for us Canucks!

Go Apple Go!

 

[applepro01]

The Health Canada link is not working

Health Canada has cleared the ECG app and irregular heart rhythm notifications on the Apple Watch Series 4, suggesting that both features will make their much-anticipated debut in Canada in the near future.

As spotted by the blog iPhone in Canada and confirmed by MacRumors, Health Canada issued active licenses for both features on May 16. The regulatory agency classifies the Apple Watch Series 4 as a Class II medical device, placing it in a "low-to-medium risk" category alongside the likes of contact lenses.

To view the licenses, navigate to the Health Canada search page and search for Apple based on company name.

The ECG app first launched in the United States last December as part of watchOS 5.1.2. The feature expanded to 19 European countries and Hong Kong in watchOS 5.2 in March and to five more European countries in watchOS 5.2.1 last week.

With clearance from Health Canada, Apple could expand the ECG app to Canada in either watchOS 5.3 or watchOS 6, the latter of which should be unveiled at Apple's annual Worldwide Developers Conference next month.

Apple Watch Series 4 users can generate an ECG waveform in just 30 seconds by placing their finger on the Digital Crown.Apple has yet to mention the ECG functionality on the Apple Watch health and fitness page on its Canadian website.

Article Link: Health Canada Gives Green Light to ECG App on Apple Watch

 

[MisterSavage]

Congrats Canadian friends. It's a great feature.

 

[HiVolt]

Took long enough. Now let's see how much Apple cares about Canadian customers to enable it before WatchOS 6 ships.

 

[PickUrPoison]

Great news about the app approval, it seemed inevitable with US/EU already approving.

A nice side benefit will be that we won’t have to listen to all the Apple-hate posted in every single ECG/watch article calling out Apple for not having even begun the approval process in Canada.

The process must have begun years ago, just like the US and EU. With those big three approvals, many other countries should soon follow along, but some will take years; the regulatory process varies greatly from country to country. But of course, any delays will be due to Apple not caring sufficiently about customers in that country

 

[Rod1949]

Link to Health Canada
https://health-products.canada.ca/mdall-limh/information.do?companyId_idCompanie=145169&lang=eng
Yes it looks like the wait is almost over. At 70 it will be a nice enhancement, just hope it doesn’t just make me worry about a non-existent problem.

 

[HiVolt]

Great news about the app approval, it seemed inevitable with US/EU already approving.

A nice side benefit will be that we won’t have to listen to all the Apple-hate posted in every single ECG/watch article calling out Apple for not having even begun the approval process in Canada.

The process must have begun years ago, just like the US and EU. With those big three approvals, many other countries should soon follow along, but some will take years; the regulatory process varies greatly from country to country. But of course, any delays will be due to Apple not caring sufficiently about customers in that country

Health Canada indicated several times via twitter replies, and as recently as in March 2019, that it had not received an application from Apple. So unless that's a lie, who knows.

 

[BuddyTronic]

Link to Health Canada
https://health-products.canada.ca/mdall-limh/information.do?companyId_idCompanie=145169&lang=eng
Yes it looks like the wait is almost over. At 70 it will be a nice enhancement, just hope it doesn’t just make me worry about a non-existent problem.

I wonder when Apple sent the application because I read an article here and elsewhere that in January 2019 supposedly the Canadian health guys “said” that Apple had not even yet applied for approval as of that date.

 

[PickUrPoison]

Health Canada indicated several times via twitter replies, and as recently as in March 2019, that it had not received an application from Apple. So unless that's a lie, who knows.

Not necessarily a lie at all, but as in most bureaucracies, sometimes the left hand doesn’t know what the right hand is doing. The PR folks who are hired to manage the Twitter account are unlikely to be aware of confidential regulatory filings, I would think.

At some point in the decades to come, maybe people will stop believing everything they read on the Internet But probably not. As long as it confirms their own opinion, many are eager to believe anything they read. If it’s the truth—but they don’t like it—it’s “fake news”.

 

[jonnysods]

Dang, makes me want to get one even more now!

 

[IIGS User]

I'm 46 and pending surgery for a major heart condition. This is one of the reasons I decided to spring for the 4 when I did. The heart rate monitor, EKG, and fall detection were major selling points for me. I mean, I love the tech (Apple pay, using the watch for texts, the info you can get from the on screen complications, etc) but this was what put me over the edge.

It's not the same as a doctor visit, but a 1 lead EKG every day is still more monitoring than my condition would get short of being held in a hospital environment. And if I go down, I know someone is coming as it reports my location) to my wife, and a friend. I use the app to list my medical condition and medications (my heart is half of it, my liver is the other). These were big selling points.

Sometimes I get tachycardia, and usually it passes. It's nice to be able to check and inform my cardiologist of what happened along with a current BP reading. This way, I know I'm not gonna plotz before I get surgery.

 

[MrPjackson]

I will buy one when it detects a heart attack or pending heart attack, or if it detects severe heart rate drop to the point it contacts emergency services.

I work alone a lot of the time and I although I am healthy I fear someday I will find myself on the floor going into cardiac arrest and nobody around to save me.

 

[MisterSavage]

Sometimes I get tachycardia, and usually it passes. It's nice to be able to check and inform my cardiologist of what happened along with a current BP reading. This way, I know I'm not gonna plotz before I get surgery.

Plus you can export a PDF of your ECG reading to show your doctor. I know it's nowhere near as good as the readouts from a doctor's office but it's a heck of a lot better than having nothing but your verbal description of how you felt.

 

[JetTester]

Great news! This, along with the other health related features, make the Apple Watch a game changer in helping improve and even save lives. Good on you Apple!

 

[Botts85]

Plus you can export a PDF of your ECG reading to show your doctor. I know it's nowhere near as good as the readouts from a doctor's office but it's a heck of a lot better than having nothing but your verbal description of how you felt.

As someone who went through intermittent arrhythmia, this is huge.

A couple times, my doctor had me on a 24 Holter Monitor, and since I didn't have an episode while wearing it, it was useless. Ultimately this led to me having a cardiac electrophysiology lab completed, which is invasive, somewhat risky, and a large cost to the medical system.

Had I been able to run an ECG when I noticed a heartbeat change and email it to my doctor or cardiologist, it may have led to a quicker diagnosis without EP lab.

 

[GregJohn]

Yes Canada! Thank you for finally getting off your lazy asses!

 

[MisterSavage]

As someone who went through intermittent arrhythmia, this is huge.

A couple times, my doctor had me on a 24 Holter Monitor, and since I didn't have an episode while wearing it, it was useless. Ultimately this led to me having a cardiac electrophysiology lab completed, which is invasive, somewhat risky, and a large cost to the medical system.

I'm curious. Why didn't they have you use a monitoring system you wear for longer like a Zio Patch before doing an invasive test?

 

[LordVic]

I'm curious. Why didn't they have you use a monitoring system you wear for longer like a Zio Patch before doing an invasive test?

probably depends on what's being measured.

having warn the halter for 2 days, it's a pretty invasive thing to have to wear. numerous probes to multiple parts of the chest. Also probably depends on how accurate they're looking for.

 

[lartola]

I will buy one when it detects a heart attack or pending heart attack, or if it detects severe heart rate drop to the point it contacts emergency services.

I work alone a lot of the time and I although I am healthy I fear someday I will find myself on the floor going into cardiac arrest and nobody around to save me.

That may be coming sooner than you think, since the Apple Watch already detects some signs that commonly precede a heart attack such as a very high resting heart rate (high heart rate notification feature) or atrial fibrillation (ECG).

 

[amssullivan28]

Still no word on TGA approval for the ECG/afib functions on the Apple Watch here in Australia.

 

[Botts85]

I'm curious. Why didn't they have you use a monitoring system you wear for longer like a Zio Patch before doing an invasive test?

Mine was in 2014. I'm not certain the Zio Patch or other longer term ambulatory monitors were approved by Health Canada at the time.

 

[lewdvig]

Took long enough. Now let's see how much Apple cares about Canadian customers to enable it before WatchOS 6 ships.

I'm sure they care exactly the right amount, i.e. about 10% as much as they would for the USA.