FDA Grants First Ever Clearance For Six-Lead Personal ECG Device

Tuesday, May 14, 2019

AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), today announced its third FDA clearance in three months, making KardiaMobile 6L the world's first available six-lead personal ECG device. This highly anticipated 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.

"KardiaMobile 6L is the most clinically valuable personal ECG ever created, and another significant step in AliveCor's march to making heart care more convenient, more accessible, and less expensive than ever before" said AliveCor CEO Ira Bahr.

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 far superior view of the heart than a single lead ECG, giving them 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 6-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, MD, cardiologist, Founder and Director or Scripps Research Translational Institute, and author of the new book "Deep Medicine."

"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 MD, Professor of Medicine, Clinical Scholar Keck School of Medicine, USC and Executive Director, USC Center for Body Computing.