FDA Clears 6-Lead KardiaMobile ECG Device

MAY 13, 2019
Cecilia Pessoa Gingerich
FDA, The US Food and Drug Administration (FDA) has granted clearance to the KardiaMobile 6L, a personal electrocardiogram (ECG) device. This is the FDA’s first clearance for a 6-lead ECG device for personal use.

"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 newly cleared device build’s on AliveCor’s KardiaMobile device, which was the first ECG device cleared by the FDA to detect the 3 most common forms of heart arrhythmia—including atrial fibrillation (AFib), bradycardia, and tachycardia. KardiaMobile has 2 electrodes at the top of the device where the user places his or her thumbs, but KardiaMobile 6L has an additional electrode that the user places on his or her left knee or ankle. The added electrode allows creates an Einthoven Triangle formation, allowing the device to measure electrical activity from 6 perspectives.

"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," said Eric Topol, MD, cardiologist, Founder and Director or Scripps Research Translational Institute. Topol added that the clearance is a welcome and an important step forward for the field of mobile heart diagnostics.

AliveCor has announced that the new KardiaMobile 6L will be made available in June 2019 and that the device may already be pre-ordered online.

"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, University of Southern California (USC) and Executive Director, USC Center for Body Computing.

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