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