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Apple Watch ECG feature requires local regulatory approval before arriving in Canadian marketplace

mardi 11 décembre 2018, 12:00 , par Power Page
If you’re north of the border, you might have to wait for some time for the ECG feature of the Apple Watch Series 4 to come your way.
In response to a query on Twitter asking if the approval process has commenced to allow the ECG function to work, government agency Health Canada advised it “has not received an application for the Apple Watch Series 4” at all.
As such, the regulator appears to be laying the blame for this at Apple’s feet, citing that “The decision to submit a medical device license application rests with the manufacturer.”

ECG monitoring is typically only performed by hardware provided to medical professionals and healthcare providers, and are typically prevented from being provided to the general public. For it to be available to use by consumers, the Apple Watch has to receive regulatory approval for the Apple Watch Series 4 on a country-by-country basis.
The ECG feature became available after the U.S. Food and Drug Administration cleared the Apple Watch Series 4 for sale, making it the smartwatch the first consumer device to do so without requiring medical review. While not available at launch, the ECG app was enabled for users in the U.S. as part of the watchOS 5.1.2 update on Thursday.
Apple has stated that it intends to bring the ECG function to other Apple Watch Series 4 users in other countries, albeit this process involves passing regulatory muster in each market, a process that can take a considerable amount of time.
Stay tuned for additional details as they become available.
Via AppleInsider and Twitter
https://www.powerpage.org/apple-watch-ecg-feature-requires-local-regulatory-approval-before-arriving...
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