FDA Approves New Personal ECG Algorithm Suite

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Kardia AI V2, AliveCor’s next generation of interpretive ECG algorithms. 

The company’s new AI technology is powered through its KardiaMobile and KardiaMobile 6L devices, in additions to its Kardia app. The technology allows users to take a 30-second ECG and receive instant determinations of multiple cardiac conditions, such as a sinus rhythm with premature ventricular contractions (PVC), a sinus rhythm with supraventricular ectopy (SVE), as well as a sinus rhythm with wide QRS.

Furthermore, the new algorithm suite boasts improved sensitivity and specificity on the company’s “Normal” and “Atrial Fibrillation” algorithms, thus leading to fewer false positives and false negatives. It also provides new visualizations on average beat, PVC identification, as well as a tachogram.

"Kardia AI V2 is the most sophisticated AI ever brought to personal ECG," said Priya Abani, CEO of AliveCor, in a statement. "This suite of algorithms and visualizations will provide the platform for delivery of new consumer and professional service offerings beyond AFib, by allowing a much wider range of cardiac conditions to be determined on a personal ECG device."

The company expects this new technology will augment remote and telehealth cardiological services for a majority of cases.

Further, they plan to use this AI as a foundation for additional services in personal and professional environments—such as advanced ECG determination services within KardiaCare; the Kardia Heart Health Report (HHR), a cardiologist-backed patient heart risk assessment report; a professional ambulatory monitoring service; as well as chronic heart disease management, which consists of combined human-backed and digital care plans for high-risk employees.

According to the release, these new determinations and services will become available for use in 2021.