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