Apple Watch AFib feature receives new FDA approval - can now be used in clinical studies

After receiving clearance in 2018, the life-saving feature breaks new ground
Wareable Apple Watch AFib History FDA MMDT approval
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The Apple Watch's atrial fibrillation (AFib) feature has become the first piece of 'digital health technology' to receive MMDT approval from the FDA, ensuring the smartwatch can now be used in clinical studies.

The AFib feature was given 510(k) 'clearance' by the FDA when it debuted in 2018 on the Apple Watch Series 4, passing the first major threshold and graded as "substantially equivalent" to some existing devices. 

Essentially, this meant the Apple Watch was seen to work similarly to already-available pulse oximeters credited with identifying AFib by using comparable technology.

And it's why we've also seen the floodgates open since the Series 4 launch, with the majority of smartwatches launched since also aiming to pick on signs of AFib through ECGs.

Receiving MMDT approval - which stands for Medical Device Development Tool - is an entirely new step for the wearables industry, however, allowing researchers to rely on data from the watch.

The FDA describes the AF History feature as a non-invasive way to check estimates of AFib burden on patients before, throughout, and after a clinical study - essentially meaning the Apple Watch can be used to measure the severity of the patient's condition and the effectiveness of treatments.

Where things go from here remains to be seen, though.

We know Apple the news represents a big step for the Apple Watch's credentials as a health tool, but it's not yet clear whether the industry will try and follow with AF History equivalents and attempt to receive MMDT nods from the FDA.

For now, at least, Apple stands alone with this latest seal of approval.


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Conor Allison

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Conor joined Wareable in 2017, quickly making a name for himself by testing out language translation earbuds on a first date, navigating London streets in a wearable airbag, and experiencing skydiving in a VR headset.

Over the years, he has evolved into a recognized wearables and fitness tech expert. Through Wareable’s instructional how-to guides, Conor helps users maximize the potential of their gadgets, and also shapes the conversation in digital health and AI hardware through PULSE by Wareable.

As an avid marathon runner, dedicated weightlifter, and frequent hiker, he also provides a unique perspective to Wareable’s in-depth product reviews and news coverage.

In addition to his contributions to Wareable, Conor’s expertise has been featured in publications such as British GQ, The IndependentDigital Spy, Pocket-lint, The Mirror, WIRED, and Metro.


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