ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom

Earlier this month, Apple unveiled the Apple Watch Series 4 with a new electrocardiogram (ECG) feature that measures the electrical activity of your heartbeat, providing you with a heart rhythm classification that can be shared with your doctor. The feature isn't out yet, but it will be limited to Series 4 models in the United States later in 2018.
Today, 9to5Mac shared a potential time window for the launch of the ECG feature in the United Kingdom. The Medicines and Healthcare products Regulatory Agency (MHRA) explains that the process starts by examining Apple's documentation surrounding the ECG feature and performing an audit of the quality assurance system.

While this step doesn't appear to be lengthy, the proceeding steps could make the process longer. MHRA says it would require Apple to perform a new clinical investigation to judge the effectiveness of the ECG on Apple Watch, but Apple would likely not be able to use any of the data from the studies it's already completed because MHRA requires companies to notify the regulator in advance of a study.

Once the study is submitted, MHRA has 60 days to approve it (which may become longer if the regulators have further inquiries for Apple), and then Apple can begin the study. These last few steps are what the MHRA say "could potentially add years" onto the debut of the ECG in the UK.

You may need to carry out a clinical investigation as part of the process to obtain a CE marking for your medical device. You must inform MHRA if you are planning to do this at least 60 days before starting your investigation [providing] some basic details about the investigational device, the intended population, the type of study, and estimated application date.

The last factor could be the most time consuming and could potentially add years onto the CE marking process.

Despite the potential for years-long approval, Apple may find ways to expedite this process. While the United Kingdom remains part of the European Union, it’s possible that Apple could receive approval from a broader regulatory body and sidestep the MHRA's processes.

In the United States, Apple has obtained de novo FDA clearance for the ECG feature in the Apple Watch Series 4 and the feature that can send a notification if an abnormal heart rate has been detected. However, FDA clearance is not the same as FDA approval and the FDA does not recommend that the ECG feature be used by those under 22 or those who have already been diagnosed with atrial fibrillation.

The FDA warns that Apple's ECG app is not designed to replace traditional methods of diagnosis or treatment and is intended for informational use only. The Series 4 is the first ECG product being offered over the counter directly to consumers.

Elsewhere, Apple has said it is working with Health Canada to bring the ECG functionality to the Canadian market, although no timeline has been specified.

Apple Watch fire face was made with actual fire

With the Apple Watch Series 4, Apple introduced a new, larger display. It now has rounded edges and thinner bezels. And the company took advantage of that display to introduce new fire, water, liquid metal and vapor faces. Apple didn’t use CGI to create those faces — they shot those faces in a studio.
Many companies would have rendered those effects on a computer given the size of the display. But those are actual videos shot with a camera.
As you can see, Apple used a flamethrower against a transparent surface, exploded a balloon at the top of a basin of water, made a color powder explosion in a cylinder and rotated a small puddle of metallic liquid.
It says a lot about Apple’s design culture — they don’t take shortcuts and they have a lot of money.

The Most Exciting Thing Apple Announced on Wednesday

It wasn’t one of the new iPhones. It was the health-focused update to the Apple Watch.

In the lead up to Wednesday’s Apple event, the Apple Watch seemed like it would be a sideshow. The device would get some minor updates, while the new iPhones would be the focus. Apple may have intended that to be the case, but the iPhone updates were mostly iterative and unsurprising (though technically impressive). Instead, the new version of the Apple Watch, already the leading smartwatch in the world, emerged as the most exciting announcement from the company.
The Apple Watch Series 4 seems like an incremental update with an initial glance at its new features. The watch has a slightly larger display with 30 percent more screen real estate on both the 40mm and 44mm variants. The back of the device is made of black ceramic and sapphire crystal, and the Digital Crown now includes haptic feedback for a more satisfying response as you turn its dial to navigate onscreen. Its speaker is 50 percent more powerful, and its microphone has been moved to the opposite side of the device to help improve phone call quality. While its overall battery life is the same as its predecessor (18 hours), its new operating system, watchOS 5, allows for improved performance when tracking fitness activities like running, which you can now do for up to six hours.
It’s the watch’s improvements in the health arena that are most noteworthy. The Apple Watch Series 4 is the first commercial “over the counter” device to gain FDA clearance for taking electrocardiogram (ECG) readings. The device has electrodes on its sapphire underside and in the Digital Crown; by touching the Digital Crown for 30 seconds, you can take an ECG reading anytime.
Once complete, Apple’s ECG app tells you your heart rate and whether you have a sinus heart rhythm, which is normal, or atrial fibrillation, an irregular heart rhythm. It’s not a replacement for a doctor, but it has FDA approval. It’s accurate enough to be taken seriously, and that’s a huge step for a consumer wearable device. The watch also keeps track of your ECG readings in the Health app, so if you do have some irregular readings, you can export them as a PDF to share with your doctor for further analysis.
According to the CDC, a quarter of deaths in the U.S. each year are due to heart disease, and somewhere between 2.7 and 6.1 million citizens have atrial fibrillation. This condition increases a person’s risk of stroke by four to five times. By identifying this heart condition earlier, an individual could start to make lifestyle changes that can reduce their chance of stroke or seek treatment earlier, before hospitalization is needed. Apple’s new health and heart rate tracking features could also be useful for those who experience other unusual cardiac events, such as an unusually elevated or unusually low heart rate. By capturing that data in a form you can directly share with a physician, you may be able to identify whether you have a heart condition or not.
Over the years, Apple’s smartwatch has evolved. At first, it seemed primarily a device for techies aimed at keeping us connected 24/7. It then became more of a lifestyle item, a stylepiece with all manner of apps available from the App Store. In its third generation, Apple focused on fitness, adding GPS, making it waterproof, and expanding its fitness-tracking capabilities. Now Apple seems to be rounding out the experience with health-focused features. The device has utility no matter which of these scenarios suits your needs, but its developments in the health sector set apart the product from other consumer-grade smartwatches and wearables on the market. Now, it doesn’t just track your heart rate—it can help accurately diagnose a common, sometimes deadly heart condition. This is a huge step for wearables, and a positive move at a time when so much of the tech world feels like it’s harming society these days.