Health Canada has granted Apple a license for the ECG app and irregular heart rate notifications feature on the Apple Watch Series 4.Both licenses were approved on May 16th and now appear in Health Canada's Active license list.
The Apple Watch is classified as a Class II medical device alongside other long term, portable ECG recorders. "An active diagnostic device, including any dedicated software, that supplies energy for the purpose of imaging or monitoring physiological processes is classified as Class II."
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