AliveCor has announced it has received US Food and Drug Administration (FDA) clearance for the next generation of KAI 12L—the artificial intelligence (AI) technology powering its Kardia 12L electrocardiogram (ECG) system—to detect five additional cardiac determinations, bringing the total number to 39 cleared determinations.
This expansion further enhances the diagnostic breadth of the “world’s first” AI-powered, handheld 12-lead ECG system with a unique single-cable design, providing healthcare providers with “unprecedented” clinical depth in a compact, portable form factor. That is according to a press release from AliveCor.
KAI 12L can now detect three additional rhythm modifiers—short PR interval, atrial bigeminy and ventricular bigeminy—and two axis-related morphology determinations—left axis deviation (LAD) and right axis deviation (RAD).
“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,” said Priya Abani, chief executive officer (CEO) of AliveCor. “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.”
AliveCor states that, since its launch in June 2024, Kardia 12L has seen growing adoption in the USA, and recently expanded into India, Australia and New Zealand, with European regulatory reviews underway. In 2025, the US Centers for Medicare and Medicaid Services (CMS) approved Medicare payment for Kardia 12L in hospital outpatient settings.
The Kardia 12L ECG system is described by AliveCor as an innovative solution using a single cable and five electrodes to acquire eight high-quality, diagnostic-bandwidth leads. Powered by KAI 12L, the system is “shifting the paradigm” in cardiac care by expanding access to accurate data across diverse healthcare and acute settings.
The company also claims that Kardia 12L’s speed and simplicity assist providers in rapid disease detection while enhancing the patient experience. A recent peer-reviewed study in Heart Rhythm O2 found that Kardia 12L reduced ECG acquisition time by 29%, enabling physicians to see more patients and act faster.
