AliveCor’s cardiac tool for Apple’s smartwatch to detect Afib gets FDA clearance

AliveCor has received FDA clearance for an EKG tool for Apple’s smartwatch that’s designed to flag atrial fibrillation. Afib is a form of arrhythmia and is associated with strokes. Clearance for the clinical-grade, consumer-facing device comes at a time when companies in the business of wearables such as Apple and Fitbit are keen to build on their health tech capabilities.

Users can record a single-lead EKG with a sensor on the Kardia Band that communicates with a companion Apple Watch app, according to a company statement. It can also let you know when you need to retake an EKG.

The Kardia Band is designed to be used with SmartRhythm in AliveCor’s Kardia watch app, which uses artificial intelligence with inputs from the watch’s heart rate and activity sensors to continuously track the correlation between heart activity and physical activity, according to a company press release. When SmartRhythm detects that heart rate and activity are out of sync, the device
notifies users to capture an EKG.

The device costs $199, but customers also have to subscribe to AliveCor’s Premium service for $99 a year.

The interest in integrating EKG tech into consumer wearables is that despite being the most common form of arrhythmia, Afib can be challenging to detect and diagnose unless data is collected over a period of time.

Apple added heart monitoring capabilities with its latest smartwatch software upgrade in September to show the user’s resting heart rate, walking heart rate, and recovery rate, and identify abnormal rates.

There’s no shortage of health tech companies that have some form of EKG sensor, and there are a wide variety of form factors used to integrate those sensors so that data can be collected easily from apparel to patches, and wrist-worn wearables. Accuracy and standardization of the data they generate remain ongoing issues. Even so, healthcare organizations are keen to research the ability of these devices to support remote monitoring between appointments, especially if consumers can use cues they receive from these devices to alert physicians to an Afib issue or another potential heart condition.

Bridging the gap between collecting information on cardiac events from these devices and ensuring that physicians get that information in a way that makes sense to their workflow without heightening their liability is essential to more mainstream adoption.