AliveCor's ECG System Receives FDA Approval

Jan. 13, 2026 —  AliveCor has received U.S. Food and Drug Administration (FDA) clearance for the next generation of KAI 12L— the AI powering the Kardia 12L ECG System — to detect five additional cardiac determinations, bringing the total to 39 cleared determinations. This expansion further enhances the diagnostic breadth of the world’s first AI-powered, handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design, providing healthcare providers with unprecedented clinical depth in a compact, portable form factor.

KAI 12L can now detect three additional rhythm modifiers: Short PR Interval (Short PR), 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, 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.”

Since its launch in June 2024, Kardia 12L has seen growing adoption in the U.S. and recently expanded into India, Australia and New Zealand, with European regulatory reviews underway. The system has been adopted by more than 250 practices, capturing critical heart data on tens of thousands of patients. Most notably, the system has identified over 4,000 instances of myocardial infarction and ischemia, facilitating life-saving care for those who need it most.

The Kardia 12L ECG System is an innovative solution using a single cable and five electrodes to acquire eight high-quality, diagnostic-bandwidth leads. Powered by KAI 12L—the world’s first AI capable of detecting life-threatening conditions like heart attacks via a reduced lead set—the system is shifting the paradigm in cardiac care by expanding access to accurate data across diverse healthcare and acute settings. Its speed and simplicity assist providers in rapid disease detection while enhancing the patient experience; notably, a peer-reviewed study in Heart Rhythm O2 found that Kardia 12L reduces ECG acquisition time by 29%, enabling physicians to see more patients and act faster.

In 2025, CMS approved Medicare payment for Kardia 12L in hospital outpatient settings, following the establishment of Category III CPT codes by the AMA in 2024. These regulatory and reimbursement milestones have been major accelerators for adoption, solidifying its place in reimbursed clinical workflows.

Kardia 12L ECG System

Kardia 12L is battery-operated, weighs just 0.3 pounds and can fit in a pocket – making it significantly smaller, more portable and more convenient than conventional 12-lead ECG machines. Its streamlined leadset also makes it less invasive for patients, who do not need to fully disrobe during a reading. The device requires minimal self-guided training and is simpler to use than standard 12-lead ECG machines.

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 AI and a reduced leadset, Kardia 12L offers outstanding clinical efficiency and performance substantially equivalent to state-of-the-art ECG analysis solutions.

For healthcare providers interested in Kardia 12L, please visit https://alivecor.com/products/kardia12l .