Second Generation On-the-Go ECG Device Gets FDA Approval

AliveCor’s KardiaMobile 6L provides detailed views into heartbeats and arrhythmias.

 While there are several on-the-go electrocardiograms (ECGs) on the market already, they all generally provide just one view of the heart, limiting their value, though that is about to change. The U.S. Food and Drug Administration has approved a second-generation device from AliveCor that has six leads that attach to both thumbs, as well as the left knee or ankle. As a result, more detailed information is provided about heartbeats and arrhythmias. 

The attachment of leads to the two thumbs and the knee or ankle completes Einthoven's triangle, which is named after the man who invented the ECG. Using three limbs with the heart at the center allows for detection of a wider range of heart conditions.

The device is paired with a smartphone and has received FDA clearance for the detection of atrial fibrillation, bradycardia and tachycardia, as well as a normal heart rhythm, over a period of 30 seconds. AliveCor expects to have the product on the market in June.


The company will also be supplying the device to China, where it estimated approximately 10 million people suffer from atrial fibrillation.

 

Emilie Branch

Emilie is responsible for strategic content development based on scientific areas of specialty for Nice Insight research articles and for assisting client content development across a range of industry channels. Prior to joining Nice Insight, Emilie worked at a strategy-based consulting firm focused on consumer ethnographic research. She also has experience as a contributing editor, and has worked as a freelance writer for a host of news and trends-related publications