Six-lead personal ECG device gets US FDA nod

July 4, 2019 0 By FM

A liveCor announced that the US FDA has cleared its KardiaMobile 6L, the world’s first available six-lead personal ECG device.

The device 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 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,” in a statement.