FDA clears first medical device accessory for Apple Watch

Kardia Band
Kardia Band (AliveCor) is an ECG reader for the Apple Watch

AliveCor has added another personal electrocardiogram (ECG) technology product to their range, announcing the US Food and Drug Administration (FDA) have cleared the Kardia Band in the USA. The Kardia Band works exclusively with the Apple Watch, providing owners of both technologies with the ability to discretely capture their ECG on the go and quickly identify arrhythmia such as atrial fibrillation (AF).

The first FDA-cleared medical device accessory for the Apple Watch, Kardia Band can record an ECG in 30 seconds with just a touch of its integrated sensor. Results from the Kardia app are displayed on the face of Apple Watch.

AliveCor is also introducing SmartRhythm, a new feature within the Kardia app for Apple Watch. SmartRhythm continuously uses artificial intelligence in concert with inputs from the watch’s heart rate and activity sensors to evaluate the correlation between heart activity and physical activity. When SmartRhythm detects that heart rate and activity are out of sync, the device alerts users to capture an ECG with either KardiaBand or KardiaMobile, AliveCor’s portable ECG reader.

“Kardia Band paired with SmartRhythm technology will be life-changing for people who are serious about heart health,” says Vic Gundotra, CEO, AliveCor. “These capabilities will allow people to easily and discreetly check their heart rhythms when they may be abnormal, capturing essential information to help doctors identify the issue and inform a clear path of care to help prevent stroke and other serious conditions.”

AF, the most common heart arrhythmia, is a leading cause of stroke, but two out of three strokes are preventable if AF is detected and treated appropriately. Kardia Band and SmartRhythm can help lower the chances of suffering a stroke while providing continuous peace of mind, AliveCor says in a statement.

Using artificial intelligence, mobile, cloud and micro-electrode technology is changing the dynamic in cardiac care. Wearable clinical devices and remote monitoring can empower and engage patients and others to proactively manage heart health, and improve quality of care, by enabling easy, quick and inexpensive detection and management of possible arrhythmia.

Kardia Band allows users to share their ECG readings via email, while KardiaGuard also includes cloud history and reporting of all ECGs ever taken, as well as a physical monthly report on all ECGs and other readings taken each calendar month.


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