FDA Clears KardiaMobile for Bradycardia, Tachycardia Detection

The US Food and Drug Administration (FDA) has granted a pair of 510(k) clearances to an electrocardiogram (ECG) device KardiaMobile to detect and show bradycardia and tachycardia ECGs.

With the indication, AliveCor’s device becomes the first and only ECG device cleared by the FDA to detect the 3 most common forms of heart arrhythmia—including atrial fibrillation (AFib).

Also capable of detecting normal sinus rhythm, the KardiaMobile device will be able to inform physicians and patients of non-AFib arrhythmias that register between 40-50 beats per minute (indicating bradycardia) or 100-140 beats per minute (tachycardia). Though both arrhythmias are commonly benign in adults, they can also indicate heart or thyroid disease.

Users of the artificial intelligence (AI)-enabled platform can also access the rhythm results via Apple Watch. Its standing as the only FDA-cleared device to pair with Apple Watch as an accessory is critical for the preemptive detection and treatment of AFib, an arrhythmia associated with a 5 times great patient risk of stroke.

In a recent interview with MD Magazine®, Larry Chinitz, MD, director of Cardiac Electrophysiology and clinical director of Cardiology at NYU Langone Medical Center, explained how the progressive burdens of the condition require appropriate and swift care.

“And one of the reasons that you really need to intervene is because of the very substantial risk of stroke,” he explained. “Stroke risks vary based on patient age and other factors, but we need to identify the patient's we need to recognize that they need therapy and we need to deliver that therapy in a prompt manner. And I think that sort of is the theme that overrides everything else that we talk about, because you can argue for hours about medical therapy versus catheter-based therapy versus surgical therapy.”

Following KardiaMobile’s indications, Jacqueline Shreibati, MD, chief medical officer of AliveCor, noted the commonality of tachycardia and bradycardia in everyday adult life—from “physical activity and sleep to emotions and overall health.”

“While we have traditionally focused on the patient empowerment that comes from increased awareness of atrial fibrillation, we are excited to give all of our users more actionable insights into their heart health,” she said in a statement.