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Apple Watch 4 Gets FDA Clearance

By MedTech Intelligence Staff
1 Comment
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The product can conduct electrocardiograms and measure the heart’s rhythms.

In addition to all the bells and whistles that come with an Apple Watch, the Series 4 product has received FDA clearance—specifically De Novo classification. Unveiled at an Apple event last week, the Series 4 watch is the first over-the-counter ECG product, according to Apple COO Jeff Williams. “Part guardian, part guru”, Apple touts the product’s ability to monitor a user’s heart rate, with an ability to detect if something is wrong, as well as fall detection (via an accelerometer and gyroscope) and Emergency SOS.

“The analytics potential of a fully medical-grade ECG on every Apple watch users’ wrist is significant, and would provide Apple with yet another hugely valuable data source on which to build additional services.” – Jeff Williams, Apple

According to Apple’s website, the watch can generate an ECG similar to a single-lead electrocardiogram, all while providing real-time data to physicians. It also has electrodes that work in conjunction with its ECG app to read the electrical signals of the user’s heart (Apple states the ECG app, along with irregular rhythm notification, will be available later this year). The data from the ECG can suggest if there is potential atrial fibrillation as well.

“With watchOS 5, Apple Watch intermittently analyzes heart rhythms in the background and sends a notification if an irregular heart rhythm such as AFib is detected. It can also alert the user if the heart rate exceeds or falls below a specified threshold.” – Apple (press release)

View Apple’s Series 4 Watch promo.


  1. William Hyman

    That Apple was successful here is further proof, if any was needed, that big companies have a big advantage in regulated digital health. They have the resources to understand the rules and play the regulatory game, while also having alternative income streams as well as money in hand. Many start-ups have no regulatory expertise, and may not even know what game they are playing.

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