AliveCor announced that the FDA now allows the company’s KardiaMobile 6L electrocardiogram (ECG) for use in measuring QTc (a heart rhythm disorder that can potentially cause fast, chaotic heartbeats) in patients with COVID-19.
The Mountain View, Calif.-based company touts its KardiaMobile 6L as the world’s only six-lead personal ECG. It is designed to detect potentially dangerous QT prolongation.
Patients with prolonged QTc are at greater risk for an arrhythmia called Torsades de Pointes, which can lead to sudden cardiac arrest or death. Drugs being used off-label to treat coronavirus, such as hydroxychloroquine and azithromycin, may cause QT prolongation or drug-induced sudden cardiac death, according to the Centers for Disease Control and Prevention (CDC).
Healthcare professionals can now use KardiaMobile 6L to calculate QT duration and assess the options for medication. AliveCor said it expects to add a professional QTc monitoring service to facilitate workflow with no on-premise calculations required.
“At AliveCor, we are committed to providing life-saving cardiological services to those who need them most,” AliveCor CEO Priya Abani said in the news release. “The benefits of remote, personal ECG measurement have never been clearer. We are thankful to the FDA for issuing timely guidance to help expand the availability of our device to assist in the treatment of COVID-19 during this global health emergency.”
“AliveCor’s KardiaMobile 6L technology can play a key role in obtaining the patient’s QTc as a vital sign to help guide the rapid and safe use of these drugs,” added Dr. Michael Ackerman, director of Mayo Clinic’s Windland Smith Rice Genetic Hearth Rhythm Clinic and Sudden Death Genomics Laboratory. “In addition, the patient’s QTc can be obtained without exposing ECG technicians to affected patients which helps to conserve personal protection equipment (PPE) and thereby expand the capacity of our strained medical resources. We are encouraged by the progress being made by regulatory authorities in allowing us to rapidly respond to the COVID crisis.”