The Food and Drug Administration (FDA) has cleared the KardiaMobile 6L electrocardiogram (ECG) device for use in measuring the QTc interval to detect potential QT prolongation.
KardiaMobile 6L is a six-lead hand-held device that can be used to obtain an ECG in 30 seconds by a healthcare professional in the office or by a patient remotely. With this approval, health care professionals can now use ECG results obtained from the KardiaMobile 6L to manually measure a patient’s QTc interval. The Company is also offering a service called InstantQT™ to assist health care professionals in measuring QT intervals through an FDA-cleared, ECG processing software.
“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 health care professionals identify and save patients from this potentially life-threatening condition.”
FDA clears personal ECG device for measurement of QTc Interval, a critical marker for patient safety. [press release]. Mountain View, CA: AliveCor, Inc.; July 8, 2021.