The Apple Watch Series 4 officially added the ECG app in the United States last week, but details regarding an international rollout remain unclear. In a post on Twitter, Health Canada said that it has yet to receive an application from Apple to bring Apple Watch ECG support to the country…
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When asked whether or not it had received a medical device application for the Apple Watch Series 4 EKG functionality, Health Canada explained that it has not yet received any such application from Apple. Further, the government department noted that the decision to submit a “medical device license application” is up to the manufacturer:
To date, Health Canada has not received an application for the Apple Watch Series 4 with the EKG feature. The decision to submit a medical device license application rests with the manufacturer.
Earlier reports had suggested that Apple was working with Health Canada to bring its Apple Watch ECG functionality to Canada, but the status of those efforts is unclear. Further, Apple Watch ECG was originally only limited by system region settings, suggesting that those settings could be changed to enable use outside of the United States.
With the official launch of the ECG feature last week, however, Apple added a new verification to render that workaround ineffective. Thus, the Apple Watch ECG app is limited solely to the United States at this time, with international rollout details unclear.
Hi Gary. To date, Health Canada has not received an application for the Apple Watch Series 4 with the EKG feature. The decision to submit a medical device licence application rests with the manufacturer.
— GovCanHealth (@GovCanHealth) December 7, 2018
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