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 patients 22 years and older, utilising data derived from 12-lead ECGs obtained during the course of routine care.
The TAP pilot provides earlier and more frequent engagement with the FDA, helping accelerate the regulatory process, enables special consideration for reimbursement by the Centers for Medicare and Medicaid Services (CMS), and ultimately speeds commercialisation for patients in need.
AK-AVS is designed to leverage the ubiquity of the ECG to identify potential cases of AVS within the millions of ECGs already present in healthcare system electronic health records, helping clinicians identify and prioritise which patients should receive an echocardiogram for definitive diagnosis. In a study published in European Heart Journal Digital Health investigators found that AK-AVS flagged AVS patients as much as 4.5 years before treatment.
“Aortic stenosis is a condition in which earlier identification can meaningfully change the trajectory of care, but today too many patients are diagnosed only after the condition is advanced,” said Fuad Jan (Aurora Health Care, Milwaukee, USA). “An ECG-based screening approach like AK-AVS has the potential to surface at-risk patients earlier in the care pathway, using data that is already being collected, and to help cardiology teams focus echocardiography resources on the patients most likely to benefit.”
“Acceptance into the TAP pilot is a significant milestone for AK-AVS and a strong signal of FDA’s continued engagement with our approach to transforming the ECG into a broader diagnostic biomarker,” said Moin Hussaini, chief product officer of AccurKardia. “We look forward to working closely with the FDA to advance AK-AVS through development and toward the patients and clinicians who need it.”
