Health Canada has not received device application for Apple Watch Series 4
As of September 14, Apple had yet to apply for medical device clearance for the Apple Watch Series 4 with Health Canada.
Health Canada has not received a medical device application for the Apple Watch Series 4 with the EKG feature – but we can deliver a decision as quickly as 15 calendar days after a company applies. More on review of digital health technologies: https://t.co/Rl9uHokXk0
— GovCanHealth (@GovCanHealth) September 14, 2018
Health Canada says it can take as few as 15 calendar days to review and decide on medical device status.
It’s one of the many health organizations that Apple will need to work with worldwide to allow its electrocardiogram to function. Electrocardiograms, which can record a person’s heart rate, are performed on the Apple Watch Series 4 with electrodes placed at the wrist-facing surface of the watch case and on the digital crown. Market analysts are banking on this feature to drive sales.
There has been concern from part of the medical community about the accuracy of the ECG function. Apple apparently had received FDA approval of the Series 4 just a day before it held its hardware launch event on September 12.
Our Jaime Rivera has just received his Apple Watch Series 4 and, during the latest episode of the Pocketnow Weekly, found that the ECG function is disallowed for the moment being.