FDA clears 1st AI smartphone device to detect 3 types of heart arrhythmia

AliveCor, the Mountain View, Calif.-based artificial intelligence and medtech company, has received FDA clearance for two more analyses on its AI-powered KardiaMobile electrocardiogram (ECG) device.

KardiaMobile was previously approved to detect atrial fibrillation (AFib) and normal sinus rhythm. As of April 24, the smartphone-compatible consumer device can also show ECG results for bradycardia and tachycardia, making KardiaMobile the only device in the world with FDA approval to detect the three most common forms of heart arrhythmia.

The product, which retails for $99, consists of a small touchpad that can be attached to a smartphone and captures a medical-grade ECG in 30 seconds. The data is automatically transferred to an accompanying app in which users can monitor their ECG results over time and email records to healthcare professionals.

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