AliveCor Secures FDA Clearance for Expanded Cardiac Determinations in Kardia 12L ECG System

AliveCor has announced U.S. Food and Drug Administration clearance for the next generation of KAI 12L, the artificial intelligence engine powering the Kardia 12L ECG System. The clearance adds five new cardiac determinations, increasing the total number of FDA-cleared determinations available on the platform to 39 and further expanding the system’s diagnostic scope.

The newly cleared determinations include three rhythm modifiers—Short PR Interval, Atrial Bigeminy, and Ventricular Bigeminy—as well as two axis-related morphology determinations, Left Axis Deviation and Right Axis Deviation. These additions build on the existing capabilities of KAI 12L and are intended to provide clinicians with a broader set of clinically relevant insights from a compact, handheld 12-lead ECG device.

Kardia 12L is designed around a single-cable, reduced-lead configuration that uses five electrodes to acquire eight diagnostic-quality leads. Powered by KAI 12L, the system has been positioned to support rapid cardiac assessment in settings where conventional 12-lead ECG machines may be impractical due to size, setup time, or infrastructure requirements. The platform has been cleared to detect serious cardiac conditions, including myocardial infarction and ischemia, using this reduced leadset approach.

“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 been adopted by more than 250 clinical practices in the United States and has expanded into India, Australia, and New Zealand, with regulatory review ongoing in Europe. According to the company, the system has been used on tens of thousands of patients and has identified more than 4,000 cases of myocardial infarction and ischemia, supporting timely clinical intervention.

Clinical efficiency has been a focus of the platform’s development. A peer-reviewed study published in Heart Rhythm O2 reported that Kardia 12L reduced ECG acquisition time by 29% compared with conventional systems. In 2025, Medicare payment for Kardia 12L in hospital outpatient settings was approved following the establishment of Category III CPT codes by the American Medical Association in 2024, supporting broader integration into reimbursed clinical workflows.

The device is battery-operated, weighs approximately 0.3 pounds, and can be carried in a pocket, offering a less invasive and more accessible alternative to traditional 12-lead ECG machines while maintaining diagnostic performance considered substantially equivalent to standard ECG analysis solutions.

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