AliveCor has received clearance for its portable ECG to calculate a patient’s QTc Interval. This FDA action follows the enforcement policy for non-invasive devices issued by the agency in March 2020 that allowed for manual QT measurement by healthcare professionals during the COVID-19 pandemic.
The QTc is a heart rate corrected interval that reflects the integrity of the heart's electrical recharging system. 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.
The Mountain View, CA-based company said with the new clearance, in just 30 seconds healthcare professionals can use the KardiaMobile 6L device to obtain an ECG which they can use to manually measure their patients’ QTc interval.
“Patient safety is paramount, and this is why we are proud to offer physicians the ability to monitor QTc through the convenience and quality of our device,” said Priya Abani, CEO, AliveCor. “It is our hope that this important FDA clearance will help healthcare professionals identify and save patients from this potentially life-threatening condition.”
This year has been eventful for AliveCor. In early June, the company acquired CardioLabs to set the stage for launching ambulatory monitoring solutions.
Most notably, AliveCor is involved in a high-profile patent dispute with Apple. AliveCor is alleging the tech giant is infringing on three counts of ECG patents and wants to block the importation of all Apple Watches in the U.S.