Apple working on Canadian approval for Apple Watch Series 4's EKG tech

Posted:
in Apple Watch
Although Apple has managed to secure U.S. Food and Drug Administration clearance for the EKG (electrocardiogram) feature on the Apple Watch Series 4, the company is reportedly still pursuing a greenlight from other governments.

Apple Watch Series 4 EKG


Apple is currently working with Health Canada to enable support in that country, according to MobileSyrup. The site noted that since Health Canada typically doesn't stray far from the FDA, Apple is likely to win clearance sometime in the near future.

The company obtained FDA clearance less than 24 hours before the Series 4 was announced, and still won't have an actual EKG app at launch. That's instead coming with a watchOS update later in 2018.

The Series 4 uses a ring on the base and a redesigned digital crown to create the equivalent of a single-lead EKG sensor. This can be used to detect atrial fibrillation, though the FDA notes that Watch owners should talk to a doctor for an actual diagnosis.

Preorders of the new Watch are underway ahead of Friday's official launch. The product's other signature features include things like a bigger display with thinner bezels, fall detection, and a faster S4 processor.

The first Apple Watch Series 4 shipments are expected to arrive with customers starting Friday morning, alongside orders for the iPhone XS and iPhone XS Max.

Comments

  • Reply 1 of 15
    I imagine that they are looking for this kind of clearance for as many countries as possible
    tipoowatto_cobra
  • Reply 2 of 15
    BebeBebe Posts: 120member
    Although this new series 4 Apple Watch is not as good as other ECG devices in the market (as "others" claimed), it is a good start.  Can't wait to get mine.
    watto_cobra
  • Reply 3 of 15
    I was hoping they would make a decent looking round watch but disappointed with this still ugly design. I got a lot of apple devices which I use daily but the watch can't stand it. Given how it looks and what it does, EKG and health, was probably designed for an elderly audience. 
  • Reply 4 of 15
    ChrisMarshall3DChrisMarshall3D Posts: 4unconfirmed, member
    Isn't it ECG not EKG?
  • Reply 5 of 15
    lkrupplkrupp Posts: 7,158member
    johnbear said:
    I was hoping they would make a decent looking round watch but disappointed with this still ugly design. I got a lot of apple devices which I use daily but the watch can't stand it. Given how it looks and what it does, EKG and health, was probably designed for an elderly audience. 
    Wow. Just wow. And FYI, the Apple Watch has already been credited with saving a couple of teenager's lives by detecting fast heartbeats. 
    edited September 2018 bb-15toysandmecaladanianboltsfan17macpluspluswatto_cobra
  • Reply 6 of 15
    Isn't it ECG not EKG?
    Both legit. Geezers like me (circa 1970) drift toward EKG. Seems like that was more common at one time (i.e. back in the daze).
    bb-15caladanianwatto_cobra
  • Reply 7 of 15
    lkrupp said:
    johnbear said:
    I was hoping they would make a decent looking round watch but disappointed with this still ugly design. I got a lot of apple devices which I use daily but the watch can't stand it. Given how it looks and what it does, EKG and health, was probably designed for an elderly audience. 
    Wow. Just wow. And FYI, the Apple Watch has already been credited with saving a couple of teenager's lives by detecting fast heartbeats. 
    Apparently only elderly people have health issues and a heart. 
    watto_cobra
  • Reply 8 of 15
    Bebe said:
    Although this new series 4 Apple Watch is not as good as other ECG devices in the market (as "others" claimed), it is a good start.  Can't wait to get mine.
    But this makes sense - i would never expect a watch to have the same level ability as a "proper" 12-lead ECG (K came from Kardio - the Germans had may of the first devices)

    So i would think manufacturers of the specialized medical devices should draw a line in the sand, but i think they also understand the benefits of easily screening a population and how more general devices can capture people who would otherwise go undiagnosed, and they will then get in for "proper" 12-lead ECGs.  


    patchythepiratewatto_cobra
  • Reply 9 of 15
    You dudes realize your Sign-in via Twitter callback URL is being rejected, ya?

    Anyhow, crazy there isn't reciprocity on this sort of thing, or at least a streamlined approval if another major country has already reviewed and approved...
    edited September 2018 watto_cobra
  • Reply 10 of 15
    sandor said:

    But this makes sense - i would never expect a watch to have the same level ability as a "proper" 12-lead ECG. 


    The best ECG device (or camera) is the one with you. By the time you get to a hospital and wired up (often hours or days later) the suspicious symptoms are no longer there to be detected and in some cases you could be dead. 
    watto_cobra
  • Reply 11 of 15
    toysandme said:
    sandor said:

    But this makes sense - i would never expect a watch to have the same level ability as a "proper" 12-lead ECG. 


    The best ECG device (or camera) is the one with you. By the time you get to a hospital and wired up (often hours or days later) the suspicious symptoms are no longer there to be detected and in some cases you could be dead. 
    Completely depends on what you are trying to find with an ECG. 
    In a relatively cardiac-unhealthy group, yes an always present monitor is great. But we need Apple to work on that battery life so you can actually monitor 24 hours.
  • Reply 12 of 15


    Anyhow, crazy there isn't reciprocity on this sort of thing, or at least a streamlined approval if another major country has already reviewed and approved...

    Those of us who work with medical devices on a daily basis have been wishing that for decades.

    FDA is only US, but a CE Mark will cover most of Europe. Canada has always been an bit of an odd-man out - we have even seen Canadian companies get their devices through the FDA first (for a larger market) and then get Health Canada approval.
  • Reply 13 of 15
    We need to recognize that the perfect is the enemy of the good. The iWatch is good enough to solve some problems. No need to not allow it because it is not perfect. The only issue with these types of devices is if people assume that they can detect all problems. They can't. But there are some problems they can detect and because they can be widely used we can hope to detect those more often and earlier. Being in Canada I have been waiting to see when we'll get support. I'll likely get one at that point.
    watto_cobra
  • Reply 14 of 15
    Isn't it ECG not EKG?
    As sandor said, both are correct. As someone in the medical field, ECG is like nails on a chalkboard. Although, of course, Apple is right to use it vs EKG.
    sandor said:
    toysandme said:
    sandor said:

    But this makes sense - i would never expect a watch to have the same level ability as a "proper" 12-lead ECG. 


    The best ECG device (or camera) is the one with you. By the time you get to a hospital and wired up (often hours or days later) the suspicious symptoms are no longer there to be detected and in some cases you could be dead. 
    Completely depends on what you are trying to find with an ECG. 
    In a relatively cardiac-unhealthy group, yes an always present monitor is great. But we need Apple to work on that battery life so you can actually monitor 24 hours.
    Apple Watch does monitor 24 hours, using the light sensor; if it picks up an aberrantly accelerated rhythm, it alerts you (and, I assume, now prompts you to take and ECG).

    As an aside, this should work equally well for panic attacks. Maybe once an arrhythmia is ruled out, it can prompt the Breathe app, or prompt a message to a comforting contact (close friend, parent, spouse, etc.). The expectation of resolution is therapeutic in and of itself.
    edited September 2018 watto_cobra
  • Reply 15 of 15
    chasmchasm Posts: 1,593member
    I believe I read somewhere that the 1-lead ECG the Apple Watch provides is 98 percent accurate (thus the unprecedented FDA approval). I'm sure a 12-lead ECG is 100 percent (rounded up from 99.8 percent or something) accurate, but ... that's pretty dang good. Also (not mentioned in the article for some reason), if the Watch detects abnormal heart rhythms et al, it tells you what to do: go see a doctor, who presumably will do a "proper" ECG.

    The reason Health Canada was mentioned is that there was an article about Apple seeking approval of it. Undoubtedly they are seeking certification with most other major health authorities all over the world, but as noted Health Canada is likely to be quick on the heels of the FDA, and believe me as a resident up here the news has gone over *very big* with athletes, students, those with disabilities, and the elderly round these parts.
    watto_cobra
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