AliveCor Gains Clearance for QTc Measurer

FDA has cleared an AliveCor 510(k) to use its KardiaMobile 6L device to calculate patients’ QTc interval. The QTc is a heart rate corrected interval that reflects the integrity of the heart’s electrical recharging system, the company says. “QT prolongation can stem from congenital long QT syndrome, many disease states or electrolyte abnormalities. Patients with a prolonged QTc are at greater risk for their hearts to go into a potentially dangerous arrhythmia called Torsades de Pointes which can lead to sudden cardiac arrest. More commonly, QT prolongation is a potential side effect of more than 100 FDA-approved medications.”

With the device, healthcare professionals can obtain an ECG within 30 seconds which they can use to manually measure their patients' QT interval, the company says. Such measurements can be performed by a healthcare professional in the office or anywhere remotely by a patient.