US-based AliveCor has received US Food and Drug Administration (FDA) approval for the next generation of its KAI 12L artificial intelligence (AI), powering the Kardia 12L ECG System.
This update allows the Kardia 12L ECG System to detect a total of 39 cardiac determinations, following the addition of five new capabilities.
The latest FDA clearance enhances the clinical range of this AI-powered handheld 12-lead ECG [electrocardiogram] system, offered in a single-cable, portable design.
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The newly cleared features include three additional rhythm modifiers: ventricular bigeminy, short PR interval (short PR), and atrial bigeminy, as well as two axis-related morphology determinations: right axis deviation (RAD) and left axis deviation (LAD).
Since its introduction in June 2024, Kardia 12L has experienced increasing acceptance across the US. It has also recently entered markets in India, Australia, and New Zealand while European regulatory assessments are currently in progress.
The system has been implemented in over 250 healthcare practices, gathering vital cardiac data from thousands of individuals. Kardia 12L has detected more than 4,000 cases of myocardial infarction and ischemia, enabling critical care for patients in urgent need.
The device utilises a single cable and five electrodes to collect eight high-quality leads. Powered by KAI 12L AI, which can detect life-threatening conditions such as heart attacks with a reduced lead set, the system aims to increase access to precise cardiac data across various healthcare settings.
A peer-reviewed Heart Rhythm O₂ study reported that Kardia 12L reduces ECG acquisition time by 29%.
In hospital outpatient settings, Medicare payment was approved in 2025 after the American Medical Association (AMA) established Category III CPT codes in 2024. These regulatory and reimbursement developments have supported its integration into clinical workflows.
AliveCor CEO Priya Abani said: “We are continuously expanding the diagnostic capabilities of our AI, and this latest clearance puts even more power into the hands of clinicians, delivering a high-fidelity 12-lead ECG, whose portable form can be deployed in any location, even in the most restricted or unconventional care settings.
“This milestone further solidifies AliveCor’s leadership in AI-powered cardiology as we continue to disrupt traditional care pathways and drive greater efficiency for healthcare providers.”
In July 2024, AliveCor unveiled the InstantQT solution in Europe to enable remote recording of point-of-care electrocardiograms.
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