AliveCor announces dual US FDA clearance of AI technology for cardiac care

AliveCor, the global leader in artificial intelligence (AI)-powered cardiology, has announced the US Food & Drug Administration (FDA) clearance and commercial launch of KAI 12L AI technology and the Kardia 12L ECG System.

This is the world's first AI that can detect life-threatening cardiac conditions, including heart attacks, using a reduced leadset. The Kardia 12L ECG System, featuring a game-changing patented technology, is the world's first AI-powered handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design.

KAI 12L employs multiple deep neural network algorithms, trained and validated on more than 1.75 million ECGs from leading US medical centers. This AI technology can detect 35 cardiac determinations (14 arrhythmias and 21 morphologies), including serious conditions like acute myocardial infarction (MI) and the most common types of cardiac ischemia, using a reduced leadset. KAI 12L can seamlessly integrate with compatible devices, including the Kardia 12L ECG System, expanding critical access to accurate heart data within a broad range of healthcare settings.

Kardia 12L ECG System is an innovative solution that requires only a single cable with 5 electrodes to acquire 8 high quality diagnostic bandwidth leads. Conventional 12-lead ECG machines are the standard of care for detecting and diagnosing many heart conditions, but their availability can be limited due to their size and complexity. Using advanced KAI 12L and a reduced leadset, Kardia 12L offers outstanding clinical efficiency and performance substantially equivalent to state-of-the-art ECG analysis solutions. Its speed and simplicity assists healthcare providers in rapid disease detection and enhancing patient experience.