Technology | ECG | May 13, 2019

FDA Clears AliveCor's KardiaMobile 6L as First Six-Lead Personal ECG Device

Six-lead ECG device builds on existing single-lead KardiaMobile

FDA Clears AliveCor's KardiaMobile 6L as First Six-Lead Personal ECG Device

May 13, 2019 — AliveCor announced its third U.S. Food and Drug Administration (FDA) clearance in three months, making KardiaMobile 6L the world's first available six-lead personal electrocardiogram (ECG) device, according to the company. This clearance gives patients and their physicians an even more detailed view into patients' hearts, including visibility into certain arrhythmias that are leading indicators of cardiovascular disease.

The KardiaMobile six-lead device is consistent in design with AliveCor's existing KardiaMobile. But, in addition to the two electrodes on the top of the device, there is one additional electrode on the bottom. The user places her thumbs on each of the two top electrodes, and places the bottom electrode on her left knee or ankle. This formation, known in cardiology as the Einthoven Triangle, allows cardiologists to view electrical activity in the heart from six perspectives, or leads. A six-lead ECG provides physicians with a superior view of the heart to a single-lead ECG, giving them the ability to detect a far broader range of arrhythmias and other heart conditions, all without the hassle of gels or wires.

"I am impressed with the quality and simplicity of six-lead smartphone ECG tracings which will unquestionably sharpen our ability to diagnose heart rhythm and conduction abnormalities. It's a welcome and needed step forward for mobile heart diagnostics," said Eric Topol, M.D., cardiologist, founder and director of Scripps Research Translational Institute.

"I am as excited for patients as I am for doctors with this clearance. One more step toward providing patients with the tools they need to drive excellence in digital healthcare," said Leslie Saxon M.D., professor of medicine, clinical scholar Keck School of Medicine, USC and executive director, USC Center for Body Computing.

KardiaMobile 6L will be available in June 2019 and may currently be pre-ordered.

For more information: www.alivecor.com

Related Content

FDA Warns Troponin Tests Impacted by Biotin Dietary Supplement
Feature | Cardiac Diagnostics | November 05, 2019 | Dave Fornell, Editor
November 5, 2019 — The U.S.
Videos | Cardiac Diagnostics | October 29, 2019
Doctor Clyde Yancy was a keynote speaker and said doctors need to check their assumptions about patients at the door...
79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event

79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event. Image courtesy of University Hospitals.

News | Cardiac Diagnostics | October 16, 2019
Health and wellness screenings are more than just nice events for the community – they can save lives. A Mentor, Ohio,...
Pesticide Exposure May Increase Heart Disease and Stroke Risk

Image courtesy of zefe wu from Pixabay

News | Cardiac Diagnostics | October 15, 2019
On-the-job exposure to high levels of pesticides raised the risk of heart disease and stroke in a generally healthy...
World Heart Federation Launches Global Roadmap on Cardiovascular Disease Prevention Among Diabetics
News | Cardiac Diagnostics | September 04, 2019
At the European Society of Cardiology (ESC) Congress 2019 together with the World Congress of Cardiology, the World...
Insomnia Tied to Higher Risk of Heart Disease and Stroke

Image courtesy of the American Heart Association

News | Cardiac Diagnostics | August 19, 2019
People suffering from insomnia may have an increased risk of coronary artery disease, heart failure and stroke,...
Evolutionary Gene Loss May Help Explain Human Predisposition to Heart Attacks
News | Cardiac Diagnostics | July 29, 2019
The loss of a single gene two to three million years ago in our ancestors may have resulted in a heightened risk of...
U.S. Soldiers Have Worse Heart Health Than Civilians
News | Cardiac Diagnostics | June 06, 2019
Active duty Army personnel have worse cardiovascular health compared to people of similar ages in the civilian...
Late Dinner and No Breakfast Worsens Outcomes After Heart Attack
News | Cardiac Diagnostics | May 23, 2019
People who skip breakfast and eat dinner near bedtime have worse outcomes after a heart attack, according to research...
HRS Releases New Expert Consensus Statement on Arrhythmogenic Cardiomyopathy
News | Cardiac Diagnostics | May 14, 2019
The Heart Rhythm Society (HRS) released a first-of-its-kind consensus statement with guidance on the evaluation and...
Overlay Init