FDA authorises AliveCor’s device to monitor adverse events of hydroxychloroquine

Allie Nawrat 7 April 2020 (Last Updated April 7th, 2020 15:25)

AliveCor's personal electrocardiogram (ECG) KardiaMobile 6L has been authorised by the US Food and Drug Administration to monitor cardiac adverse events associated with two drugs being used off-label to treat Covid-19, hydroxychloroquine and azithromycin.

KardiaMobile6L allows doctors to measure a patient's QTc, or heart rate corrected interval. Abnormal prolongation of QTc leaves patients at risk of arrhythmia, sudden cardiac arrest and sometimes cardiac death. So better knowing a patient's QTc allows doctors to make assessments and decisions about the medication they are being prescribed to treat Covid-19.

AliveCor CEO Priya Abani said: "At AliveCor, we are committed to providing life-saving cardiological services to those who need them most. 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 QTc measurement technology has been developed in collaboration with the Mayo Clinic since 2017. The clinic's Windland Smith Rice Genetic Heart Rhythm Clinic and Sudden Death Genomics Laboratory director Michael J. Ackerman added: "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.

"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."