AliveCor's Kardia AI V2 Algorithm Suite Receives FDA Clearance


AliveCor announced the US FDA has granted 510(k) clearance to Kardia AI V2 algorithm suite.

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The Kardia AI V2 algorithm suite from AliveCor has received 510(k) clearance from the US Food and Drug Administration (FDA), according to a release from AliveCor.

The new technology, which works in conjunction with the KardiaMobile and KardiaMobile 6L devices, along with the Kardia app, 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.

"Kardia AI V2 is the most sophisticated AI ever brought to personal ECG," said Priya Abani, CEO of AliveCor. "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."

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

The release went on to note AliveCor hopes this new technology will augment remote and telehealth cardiological services for a majority of cases. They also noted plans to use this AI as a foundation for additional services in personal and professional environments, including 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.

AliveCor expects the technology to become available for use in 2021.

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