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AccurKardia's ECG Software for Aortic Stenosis Enters FDA TAP Pilot

AK-AVS, an AI algorithm that reads routine 12-lead ECGs to flag possible moderate to severe aortic valve stenosis, is the company's second device in the FDA advisory program; it is not cleared or approved.

By News DeskJune 16, 20262 min read
Illustration of a patient lying in bed with ECG electrodes on the chest, arms and legs while a nurse watches a monitor, above a normal heart rhythm tracing.
An NIH illustration of a standard ECG setup and a normal heart rhythm tracing. Not an AccurKardia product. National Heart, Lung, and Blood Institute (NIH), public domain, via Wikimedia Commons · Public domain (work of the U.S. federal government)

Key points

  • AccurKardia said on June 16, 2026, that its AK-AVS aortic valve stenosis screening software was accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) pilot.
  • AK-AVS received breakthrough device designation in October 2024 and is for research use only; it has not been cleared or approved by the FDA, the company said.
  • The FDA's TAP page said in April that 122 devices were enrolled in the pilot, which offers early, frequent communication with agency advisers.

AccurKardia said on June 16 that its AK-AVS software, an artificial intelligence algorithm that analyzes routine electrocardiograms to help identify aortic valve stenosis, has been accepted into the U.S. Food and Drug Administration's Total Product Life Cycle Advisory Program (TAP) pilot. The New York company announced the acceptance in a release distributed by Business Wire, read via BioSpace.

TAP is an advisory program, not a marketing authorization. AK-AVS received breakthrough device designation in October 2024, and the company said it and its AK+ Guard software are for research use only and have not been cleared or approved by the FDA.

What the software is meant to do

AK-AVS is intended to aid in the diagnosis of moderate to severe aortic valve stenosis in adults 22 and older, using data from 12-lead ECGs recorded during routine care, according to the release. Aortic stenosis is a narrowing of the valve through which blood leaves the heart. AccurKardia said the condition is underdiagnosed because early disease often has no symptoms and detection depends on echocardiography, which is not performed routinely across the population.

The company said the software is designed to search the ECGs already stored in health system records and help clinicians identify and prioritize which patients to refer for an echocardiogram for a definitive diagnosis. It cited a study at Baylor St. Luke's Medical Center in Houston, published in European Heart Journal - Digital Health, in which investigators found that AK-AVS flagged patients as much as 4.5 years before treatment.

"Having a second device accepted into TAP reflects the pipeline we are building," said Moin Hussaini, chief product officer of AccurKardia. The company's AK+ Guard software, which assesses hyperkalemia risk from Lead I ECG data, was accepted into the pilot in January 2025.

How the TAP pilot works

The FDA's Center for Devices and Radiological Health launched the voluntary pilot as one of its commitments to industry under the MDUFA V user-fee reauthorization, according to the agency's TAP page as archived in June 2026. Its stated goal is to speed patient access to innovative devices by providing early, frequent and strategic communications with the FDA and by helping developers engage with other parties, through a dedicated group of FDA TAP advisers.

The page said that, as of April 23, 2026, 122 devices were enrolled. The pilot accepts devices with breakthrough device designation and devices in the Safer Technologies Program reviewed by specified FDA offices, including the Office of Cardiovascular Devices, and was scheduled to expand to further divisions on July 1, according to the page.

AccurKardia said in its release that TAP enables special consideration for reimbursement by the Centers for Medicare and Medicaid Services. The company did not give a timeline for an FDA submission for AK-AVS.

Sources

  1. AccurKardia's AK-AVS Aortic Valve Stenosis Screening Software Accepted into FDA Total Product Life Cycle Advisory Program (Business Wire release, read via BioSpace), BioSpace (AccurKardia release via Business Wire), June 16, 2026
  2. Total Product Life Cycle Advisory Program (TAP) (archived copy, content current as of 04/23/2026), U.S. Food and Drug Administration, April 23, 2026