FDA Clears Personal ECG Device for Measurement of QTc Interval, a Critical Marker for Patient Safety

First of its Kind FDA Action Allows In-Office and At-Home Measurement for Potentially Life-Threatening Side Effect of Certain Medications

News provided by

AliveCor, Inc.

Jul 08, 2021, 10:00 ET

MOUNTAIN VIEW, Calif., July 8, 2021 /PRNewswire/ -- AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced it received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for healthcare professionals to use the KardiaMobile 6L device to calculate patients' 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.

With this new FDA-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' QT interval. Obtaining an ECG through this device is fast, easy, and convenient as it can be done by the healthcare professional in the office or anywhere remotely by the patient. KardiaMobile 6L is the first and only hand-held ECG device that is FDA cleared for measurement of QTc.

"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."

In addition to allowing medical professionals to calculate QTc, AliveCor now offers InstantQT™, a service that measures QT intervals quickly and accurately through FDA-cleared, ECG processing software. The InstantQT service can assist healthcare professionals in detecting potentially dangerous QT prolongations in patients.

Medicines known to cause QT prolongation are commonly prescribed by healthcare professionals, who may not have ECG capabilities readily available. Some physicians view QT prolongation as a barrier to prescribing these potentially life-saving medicines. AliveCor continues to partner with biopharmaceutical companies who market medicines with this potential side effect to ensure patient safety.

About QTc
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. More commonly, QT prolongation is a potential side effect of more than 100 FDA-approved medications including certain antiarrhythmic medicines, cancer therapies, antifungals, antipsychotics, antidepressants, antibiotics, multiple sclerosis (MS) medications, and opioids, among other categories.

About AliveCor
AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile device is the most clinically validated personal ECG solution in the world. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS and Normal Heart 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 protects its customers with stringent data security and compliance practices, achieving HIPAA compliance and SOC2 Type 1 and Type 2 attestations. 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.

SOURCE AliveCor, Inc.