AccurKardia's AK-AVS™ Aortic Valve Stenosis Screening Software Accepted into FDA Total Product Life Cycle Advisory Program

AI aortic stenosis screening software accepted for FDA pilot programme

AccurKardia has announced that its AK-AVS aortic valve stenosis (AVS) screening software has been accepted into the US Food and Drug Administration (FDA) Total Product Life Cycle Advisory Program (TAP) pilot. AK-AVS, which received FDA breakthrough device designation in October 2024, is an electrocardiogram (ECG)-based artificial intelligence (AI) algorithm intended to aid in the diagnosis of moderate to severe aortic valve stenosis in adult pat…

AccurKardia's AK-AVS™ Aortic Valve Stenosis Screening Software Accepted into FDA Total Product Life Cycle Advisory Program

ECG-based AI screening tool for moderate to severe aortic valve stenosis joins select group of devices granted