New FDA Guidance Allows Use of KardiaMobile 6L to Measure QTc in COVID-19 Patients
World's only FDA-cleared six-lead personal ECG will be used by healthcare professionals to monitor QT duration in patients receiving medications that can cause potentially life threatening QT prolongation.
MOUNTAIN VIEW, Calif., March 23, 2020 /PRNewswire/ -- AliveCor, the leader in artificial intelligence (AI)-based, personal ECG technology, and provider of enterprise cardiology solutions, today announced that its KardiaMobile 6L – the world's only six-lead personal ECG – is now allowed for use in the measurement of a patient's QTc and detection of potentially dangerous QT prolongation. A prolonged QTc can lead to a potentially fatal side effect, called drug-induced sudden cardiac death (DI-SCD), associated with the use of several medicines now being used in the treatment of COVID-19.
The QTc is a heart rate corrected interval that reflects the integrity of the heart's electrical recharging system. Abnormal prolongation of the QTc can stem from congenital long QT syndrome, many disease states, electrolyte abnormalities, and over 100 FDA-approved medications that have the potential for unwanted QT prolongation. 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 and even worse, SCD. With the global pandemic of COVID-19 upon us, several drugs being used off-label to treat COVID-19 include Hydroxychloroquine and Azithromycin, have the potential for unwanted QT prolongation and worse, DI-SCD.
"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," said AliveCor CEO Priya Abani. "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," said Michael J. Ackerman M.D., Ph.D., genetic cardiologist and director of Mayo Clinic's Windland Smith Rice Genetic Heart 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." Beginning in 2017, AliveCor and Mayo Clinic have collaborated to develop advanced QT measurement technology.
With growing numbers of coronavirus cases worldwide and billions of people trying to fight off infection, the immediate availability of a device that can measure the potential life-threatening effects of medications prescribed to treat COVID-19 has never been more critical. Healthcare professionals will now be able to use KardiaMobile 6L to collect a six-lead ECG (Lead I, II, III, aVR, aVL, aV), use manual tools to calculate QT duration, and then make assessments with respect to patient medication. The KardiaMobile 6L is the only personal ECG to provide data from Lead II, which is simply unavailable from smart watch based ECGs and is critical for the detection and monitoring for potentially life threatening QT prolongation. This gives doctors, nurses, and other medical professionals the power to monitor QTc in patients receiving what will hopefully be life-saving treatment for COVID-19, whether in the hospital, or at-home.
AliveCor expects to soon add a professional QTc monitoring service which will facilitate a more seamless workflow with no on-premise calculations required.
About AliveCor AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile 6L device is the most clinically validated personal ECG solution in the world. KardiaMobile provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, and Normal rhythm in an ECG. Kardia is the first AI enabled platform to aid patients and clinicians in the early detection of atrial fibrillation, the most common arrhythmia and one associated with a highly elevated risk of stroke. AliveCor's enterprise platform allows third party providers to manage their patients and customers' heart conditions simply and profitably using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. AliveCor was named the No.1 artificial intelligence company in Fast Company's Top 50 Most Innovative Companies. AliveCor is a privately-held company headquartered in Mountain View, Calif. "Consumer" or "Personal" ECGs are ECG devices available for direct sale to consumers. For more information, visit alivecor.com.
*Mayo Clinic and Dr. Ackerman have financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.