Mobile 12-lead ECG System

Introducing Kardia 12L

The easiest way to acquire a 12-lead ECG, making critical data accessible in more places, more often.

Buy Now

For healthcare professional use only

Kardia Device
Kardia Device

Reimagining the 12-lead ECG experience.

We challenged our engineers, clinicians, and data scientists to rethink the 12-lead ECG. The resulting technology underscores our commitment to transform cardiovascular care — simplifying and expediting access to critical cardiac data.

See How

One-cable design + AI trained with one million ECGs.

The FDA-cleared Kardia 12L is an AI-powered handheld 12-lead resting ECG system. With simplified leadset technology, Kardia 12L offers outstanding clinical efficiency that expands access to 12-lead recordings in more settings than ever before.

Its unique single-cable design makes lead placement more intuitive and less error-prone, so even qualified personnel with infrequent ECG experience can acquire an accurate recording in minutes.

And with 1 million ECGs from leading U.S. medical institutions, our team developed a robust algorithm with multiple deep neural network AI models. The Kardia 12L ECG algorithm received FDA 510(k) clearance by demonstrating substantial equivalence to the state-of-the-art 12-lead ECG algorithm.

See the 35 FDA-cleared determinations it can detect.

Streamlined
3-step workflow

  • Depending on patient symptoms, the KardiaStation app will recommend using Default placement (V2, V4, RA, LA, LL) 
or Alternate placement (V1, V4, RA, LA, LL)

    Standard 12-lead ECG vs. Kardia 12L ECG report

    Comparison to conventional 12-lead results

    Recent data presented at Heart Rhythm Society 2024, "Diagnostic accuracy of a mobile, artificial intelligence-guided, 12-lead ECG device," showed results from a clinical study on 200 patients. See the side-by-side ECG reports from a standard 12-lead compared to one from the Kardia 12L for the same patients.

    The study found that Kardia 12L enabled rapid acquisition of resting ECG information, and concluded "this approach has significant implications for rapid ECG diagnosis in clinical practice."

    The poster can be accessed here.

    Additional Features

    Flexibility to use standard snap or tab electrodes.

    Expected service is 5 years.

    Capture up to 8,500 ECGs with just two AAA batteries.

    Weighs only 0.3 lbs – easily carried by hand.

    Kardia 12L detects a comprehensive set of 35 FDA-cleared determinations

    Rhythm Determinations

    Normal Sinus Rhythm
    Sinus Rhythm
    Atrial Fibrillation
    Atrial Flutter
    1st Degree AV Block
    High degree AV block (including 2nd and 3rd degree AV blocks)
    Sinus Arrhythmia
    Marked Sinus Arrhythmia
    Paced Rhythm
    Marked Bradycardia (SR, Bradycardia)
    Junctional Rhythm
    Sinus Tachycardia (SR, Tachycardia)
    Bigeminy
    PVCs

    Morphology Determinations

    Right bundle branch block (RBBB)
    Left bundle branch block (LBBB)
    Other Intraventricular Block
    Left Ventricle Hypertrophy (LVH)
    Right Ventricle Hypertrophy (RVH)
    Right Atrial Enlargement (RAE)
    Left Atrial Enlargement (LAE)
    Old Anterior MI
    Old Inferior MI
    Old Lateral MI
    Acute Anterior MI
    Acute Inferior MI
    Acute Lateral MI
    Anterior Ischemia
    Inferior Ischemia
    Lateral Ischemia
    Early Repolarization
    Prolonged QT
    Paced ECG
    Wolff-Parkinson-White (WPW)
    Normal ECG

    The provisional automated ECG analysis should not be used for clinical action if it has not been reviewed by a healthcare professional qualified to independently interpret the ECG signal. The four synthesized chest leads are not intended for diagnostic use

    To learn more about Kardia 12L, please contact us.

    Purchase Kardia 12L

    BUY NOW

    Legal

    1 Whyte, Seabrook, et al. “Diagnostic accuracy of a mobile, artificial intelligence-guided, 12-lead ECG device." Poster presented at: Heart Rhythm Society 2024; May 16-19, 2024; Boston MA, USA.

    2
    The provisional automated ECG analysis should not be used for clinical action if it has not been reviewed by a healthcare professional qualified to independently interpret the ECG signal. The four synthesized chest leads are not intended for diagnostic use

    Kardia 12L is intended for use by qualified healthcare professionals or trained personnel.