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

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