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Apple Watch Series 4's EKG feature could take years to get approved in other countries

Apple Watch Series 4 can detect Atrial Fibrillation and has an accuracy rate of 98 percent.

  • Published: September 28, 2018 12:21 PM IST
Apple Watch Series 4 lead

Apple launched Apple Watch Series 4 at its fall iPhone event early this month. The Apple Watch Series 4 features a ceramic back and brings major redesign with bigger edge-to-edge display than the Series 3. However, the big highlight of the new Apple Watch Series 4 is its ability to record electrocardiogram.

With the EKG feature, Apple aims to offer better insight into the status of your heart. The new Apple Watch comes with improved sensors to detect irregularity with the functions of your heart and will be capable of detecting one key metric called Atrial Fibrillation. At the event, Apple announced that the EKG feature on the Apple Watch Series 4 will be enabled with a future update. In order to enable the feature, Apple has already received FDA approval but in other parts of the world, it may take years for the approval.

Apple got the US FDA approval just one day before the launch and its accuracy rate of 98 percent in detecting AFib might not convince a lot of regulators. According to 9to5Mac, it might take several years before Apple could enable the EKG feature on the Apple Watch Series 4 in the UK. The Medicines and Healthcare products Regulatory Agency, which oversees approval of medical devices, says the process would not be long but testing could take years.

“ECG devices for self-monitoring are classified as class 2a and the manufacturer will require a Notified body to carry out a conformity assessment. The most common assessment route is by audit of the full quality assurance system,” the MHRA in the UK told the Apple blog.

Apple has already conducted such medical study evaluating the effectiveness of Apple Watch Series 4‘s EKG feature but the reports indicate MHRA won’t be happy with just that much data. It would actually require Apple to notify them in advance about its intention to carry out such a study.

The process would involve MHRA examining the documents from Apple and ensure that quality assurance does guarantee effectiveness and reliability around the feature. It also notes that Apple might be asked to carry out clinical investigation designed to test the effectiveness of the AFib detection. The MHRA has 60 days to approve the study and then if it has any query, the process of approval will only take longer.

Watch: Apple Watch Series 4 First Look Video

One German cardiologist told Heise in an interview that a “CE certification will come relatively quickly” if Apple manages to get approval from MHRA in the UK. There is a possibility that Apple is already working on conducting such medical test for the MHRA and gain equivalent approval from authorities in Europe.

  • Published Date: September 28, 2018 12:21 PM IST