Alivecor wins FDA clearance for next-gen interpretive ECG algorithms - MassDevice

AliveCorAI-based electrocardiogram (ECG) technology developer AliveCor announced that it received FDA clearance for its next-gen ECG algorithms.

Mountain View, Calif.-based AliveCor’s next-gen interpretive ECG algorithms, called Kardia AI V2, offers users a way to take a 30-second ECG and receive instant determinations of multiple cardiac conditions through the company’s KardiaMobile and KardiaMobile 6L devices and the Kardia app, according to a news release.

The next-generation algorithm determines if two or more ventricular ectopic beats are detected, if narrow-complex ectopy are detected and if there are QRS intervals of 120ms or longer. Additionally, the AI reduces the number of “Unclassified” readings for more reliable insight, offers improved sensitivity and specificity to reduce false results and presents new visualizations, including average beat, PVC identification and a tachogram.

“Kardia AI V2 is the most sophisticated AI ever brought to personal ECG,” AliveCor CEO Priya Abani said in the release. “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 news follows AliveCor’s announcement last week that it closed a $65 million Series E financing round, earmarking the proceeds for accelerating the growth of its remote cardiology platform, both domestically and globally, according to a news release.

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