AccurKardia’s Aortic Valve Stenosis Screening Software Enters FDA TAP Pilot

AccurKardia announced that its AK-AVS aortic valve stenosis (AVS) screening software was accepted into the U.S. Food and Drug Administration (FDA)’s Total Product Life Cycle Program (TAP) pilot.

AK-AVS earned FDA breakthrough designation in October 2024. The ECG-based artificial intelligence (AI) algorithm is intended to aid in diagnosis of moderate to severe aortic valve stenosis in adult patients 22 years and older. It uses data derived from 12-lead ECGs obtained during routine care.

The TAP pilot offers earlier, more frequent engagement with the FDA to help speed the regulatory process and enable special consideration for reimbursement by the Centers for Medicare and Medicaid Services (CMS). AK-AVS joins the company’s AK+ Guard hyperkalemia software, which was accepted into the TAP pilot in January 2025.

AK-AVS leverages 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 prioritize which patients should receive an echocardiogram for definitive diagnosis. In a recent study conducted at Baylor St. Luke’s Medical Center in Houston, investigators found that AK-AVS flagged AVS patients as much as 4.5 years before treatment.

Comments from AccurKardia and clinicians

Moin Hussaini, chief product officer, AccurKardia: “Having a second device accepted into TAP reflects the pipeline we are building. Rather than advancing a single algorithm, we are working to establish the ECG as a screening biomarker across multiple high-burden conditions, backed by clinical evidence and a clear regulatory strategy. 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. We look forward to working closely with the FDA to advance AK-AVS through development and toward the patients and clinicians who need it.”

Fuad Jan, MD, associate program director, Cardiovascular Disease Fellowship, Interventional Cardiology, Cardiology Faculty, Aurora Health Care: “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. 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.”