FDA Approves First Six-Lead Personal ECG Device

On May 13, the U.S. Food and Drug Administration cleared AliveCor's KardiaMobile 6L as "the world's first available six-lead personal ECG device."

According to an announcement from the company, the KardiaMobile six-lead device is consistent in design with the 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 their thumbs on each of the two top electrodes, and places the bottom electrode on their left knee or ankle.

Two recent poster presentations during ACC.19 in New Orleans looked at AliveCor's mobile ECG platform.

One study by Shone Almeida, MD, et al., looked at 322 patients over two years and found that "The physician and patient experience was positive resulting in the detection of atrial fibrillation well outside the time limits of many remote event recorders. A management system for smartphone EKGs represents a novel pathway for cardiac arrhythmia management with potential clinical and cost effectiveness."

Another study by Matthew Schram, PhD, et al., concluded that "an artificial intelligence algorithm for QTc estimation from a multilead smartphone-enabled ECG could potentially facilitate QT screening for the early detection of acquired or congenital long QT syndrome."

Clinical Topics: Arrhythmias and Clinical EP, Congenital Heart Disease and Pediatric Cardiology, Genetic Arrhythmic Conditions, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias

Keywords: ACC Advocacy, Atrial Fibrillation, Cost-Benefit Analysis, United States Food and Drug Administration, Electrocardiography, Artificial Intelligence, Algorithms, Long QT Syndrome, Electrodes

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