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Since the first Apple Watch tablets were sold a few years ago, Apple has consistently refused to release specific sales figures for its increasingly popular notebook. In fact, most Apple executives have told us that sales have continued to increase over the years as the company continues to add exciting features to each new refresh cycle. With the Apple Watch Series 4, Apple has undoubtedly introduced the most significant update of its notebook since the creation of the device. Aside from the significantly faster internal components, the Apple Next-gen watch has a much larger screen and improved functionality for monitoring health and fitness.
On this last point, one of the surprising features of the Apple Watch Series 4 is the ECG's support for the device. In other words, the next-generation Apple Watch can read electrical signals from a user's heart. As Apple notes on its website, this feature can be used to indicate whether someone "shows signs of atrial fibrillation – a severe form of irregular heartbeat – or sinus rhythm, which means that your heart beats normally.
The ECG's support on the Apple Watch is expected to arrive later this year, but features will be limited in the US at the moment. Earlier this month, Apple was keen to point out that the ECG application of the device had been approved by the FDA. Even so, receiving similar approvals from regulators in other countries could prove more difficult.
At this point, 9to5Mac adds that the Medicines and Health Products Regulatory Agency (MHRA) – which oversees the safety and effectiveness of medical devices in the UK – could ask Apple to conduct a medical study complete before giving the green light to the application. Apple has, of course, done studies on the US performance of the feature, but the MHRA may not be satisfied because it typically requires companies to give them a minimum of 60 days notice to approve given study. In other words, Apple might have to do things from scratch when it comes to getting an approval in the UK.
Note the language below:
You may need to perform a clinical investigation as part of the process of obtaining CE marking for your medical device. You must inform MHRA if you plan to do so at least 60 days before you begin your investigation.
Is it possible that Apple has already obtained such approval? Perhaps It is certainly plausible that Apple – which employs a number of health professionals specializing in this type of regulatory issue – is more advanced than we know. Of course, Apple has not clarified the question, but it goes without saying that the company will be more open with new details when the application will be launched in the United States.
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