FDA clears AliveCor's mobile 6-lead ECG

With a third electrode on the bottom of the device, the pose forms a triangle of ECG leads across the three limbs, placing the heart at the center. (AliveCor)

While other on-the-go electrocardiograms may only observe the heart’s electrical signals from a single angle, AliveCor has moved ahead to secure an FDA clearance for its personal device offering six leads, providing more detailed views into heartbeats and arrhythmias.  

The former Fierce 15 winner’s KardiaMobile 6L looks and acts similar to its predecessor, with two thumb-pad electrodes on the top of the card-sized ECG. The upgrade comes with the addition of a third electrode on the bottom, to be held on top of the left knee or ankle.

In this pose, the device forms what’s known as Einthoven's triangle, named for the inventor of the ECG, made up of leads from three limbs and the heart at the center. The company said this allows the user to detect a broader range of heart conditions when pairing the device with their smartphone.

"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," CEO Ira Bahr said in a statement.

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The device is cleared to detect atrial fibrillation, bradycardia and tachycardia, as well as a normal heart rhythm, over a period of 30 seconds. The company is currently taking preorders for the device and plans to make it available in June.

The FDA green light is the company’s third in the past three months, following additional clearances for its two-electrode device to spot bradycardia and tachycardia, two of the most common irregular heartbeats.

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Additionally, AliveCor recently signed a partnership in China to supply its device to the country. The company estimates about 10 million people there are living with atrial fibrillation, among 300 million with heart disease.