FDA expands approval for KardiaMobile to include bradycardia and tachycardia detection

AliveCor announced two additional FDA 510(k)-cleared indications, making KardiaMobile the only consumer ECG device in the world with FDA-clearance to detect the three most common heart arrhythmias. In addition to detecting Atrial Fibrillation (AFib) and Normal Sinus Rhythm, AliveCor is now approved to detect and show ECG results for Bradycardia and Tachycardia. These instant analyses indicate arrhythmias that are not AFib and that are between 40-50 beats per minute (Bradycardia), or between 100-140 beats per minute (Tachycardia).

Comment: The FDA granted approval for atrial fibrillation detection in August 2014. KardiaMobile when paired with the Kardia app, provides instant analysis for detecting Atrial Fibrillation, Bradycardia, Tachycardia, and Normal rhythm in an ECG. Kardia is the first A.I. enabled platform to help clinicians manage patients for the early detection of atrial fibrillation, the most common cardiac arrhythmia and one that leads to a five times greater risk of stroke. KardiaBand is the first FDA-cleared medical device accessory for Apple Watch.