FDA Clears AI Program Powering Kardia 12L Electrogram for 5 New Cardiac Determinations

On January 13, 2026, AliveCor announced that the US Food and Drug Administration (FDA) has cleared the next generation of KAI 12L, the AI powering the Kardia 12L Electrocardiogram (ECG) System, for five additional cardiac determinations.1

Kardia 12L is the world’s first AI-powered handheld 12-lead ECG system – this clearance brings the device’s total number of cleared determinations up to 39. These new determinations include 3 rhythm modifiers – short PR interval, atrial bigeminy, and ventricular bigeminy – and 2 axis-related morphology determinations – Left Axis Deviation (LAD) and Right Axis Deviation (RAD).1

“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,” Priya Abani, chief executive officer of AliveCor, said in a statement. “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.”1

The device itself is battery-operated and weighs 0.3 pounds, making it substantially smaller and more portable than standard 12-lead ECG machines. It is also significantly less invasive by virtue of not requiring patients to fully disrobe before a reading.1

Kardia 12L was first launched in June 2024, after which point it saw substantial growth in the US and expansion into India, Australia, and New Zealand. Additionally, according to AliveCor’s press release, the system has identified >4000 instances of myocardial infarction and ischemia. Recent research from August of 2025 reinforced the device’s efficacy, during which time patients visiting the electrophysiology clinic at Northwestern Memorial Hospital were given a Kardia 12L ECG rather than a standard 12-lead ECG.1,2

During this trial, a total of 50 patients were administered a Kardia 12L ECG, with a primary indication for electrophysiology clinic appointments being for evaluation of atrial fibrillation or atrial flutter (74%) or premature ventricular contractions (6%). The most common recorded rhythms on the Kardia 12L ECG were normal sinus rhythm (60%), atrial and/or ventricular paced (20%), atrial fibrillation (10%), and sinus rhythm with premature ventricular contractions (10%).2

Investigators saw that average time of Kardia 12L ECG acquisition was substantially shorter than that of a standard 12L ECG (Kardia 12L: 7.1 [6.2-8.3] minutes; standard 12L: 10 [8.7-12] minutes; P <.001) A total of 5 patients initially had a Kardia 12L ECG and necessitated an additional standard 12L ECG – reasons for this acquisition included poor signal quality (n = 2) and inability to definitively measure the QT interval due to printer settings (n = 3).2

The investigators ultimately concluded that Kardia 12L offers a substantial time advantage over traditional 12L ECGs, without sacrificing diagnostic reliability. A low necessity for follow-up dedicated 12L ECGs further supports its role in the clinical setting.2

References

1. AliveCor, Inc. AliveCor Announces FDA Clearance of New Cardiac Determinations for Kardia 12L ECG System, Bringing Total to 39. GlobeNewswire. January 13, 2026. Accessed January 13, 2026. https://www.globenewswire.com/news-release/2026/01/13/3217859/0/en/AliveCor-Announces-FDA-Clearance-of-New-Cardiac-Determinations-for-Kardia-12L-ECG-System-Bringing-Total-to-39.html

2. Gaddam M, Peigh G, Banani S, Passman RS. Efficiency of an artificial intelligence-aided portable 12-lead Electrocardiogram Acquisition System. Heart Rhythm O2. 2025;6(8):1232-1233. doi:10.1016/j.hroo.2025.05.025