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AliveCor’s KardiaMobile 6L technology has received the US Food and Drug Administration (FDA) approval to measure QTc and detection of potentially dangerous QT prolongation in coronavirus (Covid-19) patients.
The heart rate corrected interval QTc reflects the integrity of the heart’s electrical recharging system.
Its abnormal prolongation can stem from congenital long QT syndrome, many disease states and electrolyte abnormalities. It can also be caused by several of the FDA-approved medications.
Patients with a prolonged QTc are at a risk for Torsades de Pointes that can cause sudden cardiac arrest or even sudden cardiac death (SCD).
The company noted that the drugs being used off-label to treat Covid-19 have the potential for unwanted QT prolongation and drug-induced SCD (DI-SCD) in patients.
The drugs include Hydroxychloroquine and Azithromycin.
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.”
KardiaMobile 6L is considered to be six-lead personal ECG. It helps in obtaining the patient’s QTc as a vital sign to allow rapid and safe use of the drugs.
In addition, the technology will allow ECG technicians to collect QTc without exposing them to the affected patients.
The immediate availability of the device is expected to bring down the life-threatening effects of Covid-19 drugs.
AliveCor expects to add a professional QTc monitoring service soon. It will facilitate a seamless workflow with no on-premise calculations required.