Apple Working With Health Canada to Bring Apple Watch Series 4's ECG Functionality to Canadian Market
Apple says it is working with Health Canada to bring the Apple Watch Series 4's all-new ECG functionality to the Canadian market, according to MobileSyrup's Patrick O'Rourke. No timeframe was specified.
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This likely means that Apple has submitted an application with Health Canada for clearance to sell the Apple Watch Series 4 with the ECG functionality enabled. Health Canada has similar requirements as the FDA in the United States for medical devices to be sold in the country.
In the meantime, Apple says the ECG functionality will be limited to the United States, where it has received clearance from the FDA. However, the ECG app for watchOS 5 won't be available until later this year.
Apple Watch Series 4 models include a new electrical sensor on the rear that's designed to take an electrocardiogram using Apple's ECG app, the built-in sensor, and the electrode built into the Digital Crown. This allows the Watch to display a single-channel ECG, similar to a Lead I ECG, according to the FDA.
To take an ECG reading from the Apple Watch, users will need to place a finger on the Digital Crown while wearing the watch. The reading is completed in 30 seconds, allowing users to determine whether their hearts are beating in a regular pattern or if there are signs of atrial fibrillation.
As a potentially life-saving feature, Apple surely wants the ECG functionality to be available in as many countries as possible, so it's likely the company is working with public health agencies in other countries too.
Via: iPhone in Canada
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https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/rss/dhp-mps/devices-instruments-eng.xml