Personal electrocardiogram (ECG) devices provide a view of the heart to help patients and physicians detect arrhythmia and other conditions. With ECGs, the more information the better, which translates to viewing the heart’s electrical activity from a greater number of perspectives or “leads.” We’ve written about personal ECG devices since 2014 when the FDA gave AliveCor clearance for its Heart Monitor single-lead ECG smartphone accessory. Since that first mention, we noted AliveCor’s FDA clearance for automated ECG reading analytical algorithms in 2015 and in 2016, a big win when the FDA cleared AliveCor’s clinical-grade ECG technology in a replacement band for the Apple Watch.
AliveCor‘s KardiaBand watch band and KardiaMobile single-lead devices have continued to advance the field, with FDA approval, but this year the company achieved a new first. The FDA recently approved AliveCor’s KardiaMobile 6L, a six-lead mobile ECG device. Similar in design to the current 1-lead KardiaMobile, the 6L has two electrodes on top of the unit, one at each end, and a third electrode on the bottom. The user holds a thumb on each top electrode and puts the bottom electrode on their left ankle or knee. Known as the Einthoven Triangle, the heart’s electrical activity readings from this arrangement results in six different perspectives of the heart’s activity.
According to AliveCor, the 6L captures medical-grade ECGs in 30 seconds and can detect normal heart rhythm, tachycardia, bradycardia, and atrial fibrillation. The KardiaMobile 6L is available for pre-order now on AliveCor’s website for $149, with shipping expected to begin in June.
Trackbacks/Pingbacks