AccurKardia Receives FDA Breakthrough Device Designation for First-of-its-Kind Aortic Valve Stenosis ECG-based AI Screening Software
NEW YORK–(BUSINESS WIRE)–AccurKardia, an innovator in ECG-based diagnostics technology, has announced that its Aortic Valve Stenosis (AVS) ECG-based AI screening software has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The company’s AVS screening software aims to leverage the ubiquity of the electrocardiogram (ECG) to identify potential cases of AVS within millions of ECGs already present in healthcare system electronic health records in order to help identify and prioritize which patients should receive echocardiograms for definitive diagnosis.
