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 accelerated FDA engagement

NEW YORK--(BUSINESS WIRE)--AccurKardia, an innovator in ECG-based diagnostics technology, today announced that its AK-AVS™ aortic valve stenosis (AVS) screening software has been accepted into the U.S. 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 ECG-based AI algorithm intended to aid in the diagnosis of moderate to severe aortic valve stenosis in adult patients 22 years and older, utilizing data derived from 12-lead electrocardiograms (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 commercialization for patients in need. AK-AVS joins AccurKardia's AK+ Guard™ hyperkalemia detection software, which was accepted into the TAP pilot in January 2025, making AccurKardia one of a small number of companies with multiple Breakthrough-designated devices enrolled in the program.

Aortic valve stenosis is one of the most common and serious valvular heart diseases. Aortic stenosis of any severity affects an estimated 12.4 percent of adults over the age of 75, with severe disease present in roughly 3.4 percent.ⁱ Moderate to severe AVS carries a poor prognosis if left untreated, yet it remains substantially underdiagnosed because early disease is often asymptomatic and detection currently depends on echocardiography, which is not routinely performed at the population level.

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 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.ⁱⁱ

"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, MD, associate program director, Cardiovascular Disease Fellowship, Interventional Cardiology, Cardiology Faculty, Aurora Health Care. "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."

"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," said Moin Hussaini, chief product officer of AccurKardia. "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."

About AccurKardia

AccurKardia is an ECG-led diagnostics software company focused on transforming ECG data into a more powerful diagnostic tool and broad biomarker to improve patient outcomes and save lives globally. With initial applications in cardiology, the company offers transformative, cloud-based diagnostic tools, including AccurECG™ 2.0, an FDA-cleared Class II software as a medical device (SaMD) for fully automated, near real-time ECG interpretation. AccurKardia is also advancing an investigational pipeline of ECG-based biomarkers, including AK-AVS™ for aortic stenosis risk assessment and AK+ Guard™ for hyperkalemia risk assessment using Lead I ECG, both of which have received FDA Breakthrough Device Designation. AK+ Guard was awarded the “Best New ECG Technology Solution” in the 10^th annual MedTech Breakthrough Awards in 2026. For more information, please visit www.accurkardia.com.

Disclaimers:

AK-AVS and AK+ Guard are currently for research use only and have not been cleared or approved by the U.S. FDA for use in the United States. This technology is under development and intended solely for investigational purposes. For detailed technical AccurECG 2.0 requirements, relevant disclosures, and approved indications for use, please refer to the U.S. FDA 510(k) K252361 summary and product labeling.

ⁱ Osnabrugge, RLJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013 Sep 10;62(11):1002-12. doi: 10.1016/j.jacc.2013.05.015. Epub 30 May 2013.

ⁱⁱ Segar, MW et al. Validation and longitudinal trajectory analysis of an AI-based ECG model for aortic stenosis: from community screening to pre-TAVR risk stratification. European Heart Journal - Digital Health, Vol. 7, Iss. 2, March 2026, ztag018, https://doi.org/10.1093/ehjdh/ztag018. Pub 03 February 2026.