AccurKardia wins FDA breakthrough nod for ECG-based AI screening software

AccurKardia announced that it received FDA breakthrough device designation for its aortic valve stenosis (AVS) ECG-based AI screening software.

New York-based AccurKardia’s AVS screening software aims to leverage ECG to identify potential cases of AVS within millions of ECGs already present in healthcare system electronic health records. It aims to identify and prioritize which patients should receive echocardiograms for definitive diagnosis.

Last year, the company won FDA clearance for its cloud-based ECG interpretation software.

AccurKardia’s latest breakthrough technology addresses the challenges of identifying AVS with a practical solution that complements a readily available diagnostic test in the ECG. This helps to identify at-risk patients earlier and more efficiently. AccurKardia says the solution could particularly prove useful in underserved regions without readily available cardiology specialists and advanced imaging.

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