FDA Clears AliveCor’s Electrocardiogram AI Suite

AliveCor has received 510(k) clearance for the second generation of Kardia AI, an artificial intelligence (AI)-based group of interpretive electrocardiogram (ECG) algorithms.

The suite uses the company’s KardiaMobile and KardiaMobile 6L devices, as well as a smartphone app, to take a 30-second ECG and provide instant remote measurements of multiple cardiac conditions.

The system provides several algorithms for heart conditions that can be run remotely, including normal and atrial fibrillation algorithms with improved sensitivity and specificity.