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.

For healthcare professional use only

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.

For healthcare professional use only

CONTACT US

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

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.

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

Step1: Get started with the KardiaStation App

The KardiaStation app, compatible with most smartphones and tablets, guides users in selecting one of two lead set placement options depending on patient symptoms.

From KardiaStation, record a 12-lead ECG with just five electrodes. Providing eight standard diagnostic-bandwidth leads, it synthesizes the remaining four leads.

It can detect 35 determinations (14 arrhythmias and 21 morphologies) — including acute myocardial infarction (MI) and the most common types of cardiac ischemia. 

Recordings from the app can easily be sent to colleagues for quick review. Patient data are automatically uploaded to the KardiaPro® web portal, a secure and streamlined platform to manage and review patient ECG history.

Streamlined
3-step workflow

Step1: Get started with the KardiaStation App

The KardiaStation app, compatible with most smartphones and tablets, guides users in selecting one of two lead set placement options depending on patient symptoms.

From KardiaStation, record a 12-lead ECG with just five electrodes. Providing eight standard diagnostic-bandwidth leads, it synthesizes the remaining four leads.

It can detect 35 determinations (14 arrhythmias and 21 morphologies) — including acute myocardial infarction (MI) and the most common types of cardiac ischemia. 

Recordings from the app can easily be sent to colleagues for quick review. Patient data are automatically uploaded to the KardiaPro® web portal, a secure and streamlined platform to manage and review patient ECG history.

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)

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, here.

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.”

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, here.

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.”

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.

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
3rd Degree AV Block (Complete AV Block)
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 or purchase Kardia 12L, please contact us.

CONTACT US

 

To learn more or purchase Kardia 12L, please contact us

CONTACT US

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.