FDA clears AliveCor's personal ECG algorithm suite

AliveCor announced Monday that it received FDA 510(k) clearance for Kardia AI V2, its next generation of interpretive electrocardiogram (ECG) algorithms. "This suite of algorithms and visualisations will provide the platform for delivery of new consumer and professional service offerings beyond [atrial fibrillation], by allowing a much wider range of cardiac conditions to be determined on a personal ECG device," said CEO Priya Abani.

The company's KardiaMobile and KardiaMobile 6L devices, in addition to the Kardia app, allow users to take a 30-second ECG and receive instant determinations of multiple cardiac conditions, including sinus rhythm with premature ventricular contractions (PVC), sinus rhythm with supraventricular ectopy and sinus rhythm with wide QRS. 

According to AliveCor, the suite features improved sensitivity and specificity on its "normal" and "atrial fibrillation" algorithms, which will provide users with fewer false positives and negatives. It also provides new visualisations, including average beat, PVC identification and a tachogram. 

The company said it expects the algorithm suite to "augment telehealth services and provide the foundation for a new range of professional and consumer services." These include the launch of its Kardia Heart Health Report, advanced ECG determination services within KardiaCare, a professional ambulatory monitoring service using the AliveCor 6L ECG device at home, and chronic heart disease management, which combines human-backed and digital-care plans to manage cardiac health among high-risk employees. The new determinations and services will be available in 2021.

Earlier this month, AliveCor said it raised $65 million to advance its remote cardiology platform globally.

To ensure you don't miss other Top Stories like these, sign up for our free daily e-newsletter here.  

Did you like this article?