AliveCor earns another FDA nod for AI-powered 12-lead ECG tech

AliveCor announced today that it received FDA clearance for the next generation of its AI technology for the Kardia 12L ECG system.

KAI 12L, the AI powering the Kardia 12L ECG system, can now detect five additional cardiac determinations with the clearance. That brings the total for the 12-lead electrocardiogram (ECG) technology to 39 cleared determinations.

Mountain View, California–based AliveCor develops the first-of-its-kind handheld ECG system to detect various cardiac conditions. It leverages the KAI 12L deep neural network machine learning AI model, an advanced AI software algorithm trained on more than 1 million recorded ECGs. Its nearly 40 determinations include myocardial infarction (heart attack) and the most common types of cardiac ischemia.

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