3 Important Considerations in the Apple Watch ECG Announcement – Current by an author

… what Apple has done with its new Apple Watch is not particularly innovative.

AliveCor has built a virtually identical product, with the only real differentiation being the now deeper integration with the Apple Watch. AliveCor achieved its first FDA clearance for prescription use in 2012. They followed this up with over-the-counter use in 2014. At this stage, the AliveCor product was built into the back of an iPhone case. Later in 2014, AliveCor added Atrial Fibrillation (AF) detection to its FDA clearance/ Finally, in 2017 AliveCor launched the Kardia Band, building ECG monitoring into the strap of the Apple Watch.

It is also notable that, when comparing the intended use of AliveCor and the Apple Watch FDA clearances, the intended use of AliveCor is significantly stronger. The Apple Watch ECG monitoring function is not intended for those with pre-existing arrhythmias, whereas the AliveCor product explicitly states that it can be used in this patient group. For Apple, the intended use states: “It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis.” There is no such caveat in the AliveCor intended use.

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