AccurKardia Receives FDA Breakthrough Device Designation for First-of-its-Kind Aortic Valve Stenosis ECG-based AI Screening Software

AccurKardia Receives FDA Breakthrough Device Designation for First-of-its-Kind Aortic Valve Stenosis ECG-based AI Screening Software

MEDIA CONTACT:
Sam Choinski
Pazanga Health Communications
schioinski@pazangahealth.com
(860) 301-5058

AccurKardia, an innovator in ECG-based diagnostics technology, has announced that its Aortic Valve Stenosis (AVS) ECG-based AI screening software has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The company’s AVS screening software aims to leverage the ubiquity of the electrocardiogram (ECG) to identify potential cases of AVS within millions of ECGs already present in healthcare system electronic health records in order to help identify and prioritize which patients should receive echocardiograms for definitive diagnosis.

“AccurKardia’s recent advancement has the potential to create a paradigm shift in the detection of aortic valve stenosis, where earlier detection and treatment may mean the difference between life or death,” said Dr. Eduardo Hernandez, president, The Texas Heart Institute Center for Cardiovascular Care. “Once FDA-cleared and successfully deployed, this technology could become established as a standard-of-care screening tool for AVS in elderly patients.”

Aortic valve stenosis is a structural heart condition that frequently occurs in elderly patients and is life-threatening if not detected and treated early. It is typically identified via bedside examination and auscultation, with definitive diagnosis via echocardiography. However, many patients are missed by current practice due to a variety of reasons including poor symptom recognition by the elderly, the lack of murmur in some cases, the time-constrained environment of primary care visits, and limited access to echocardiography.

The impact of underdiagnosing aortic valve stenosis is substantial. The mortality rate of untreated AVS can be as high as 50 percent within one year¹, and untreated cases result in approximately $10,000 in increased healthcare expenses per patient per year versus treated cases². Yet up to 50 percent of AVS cases are missed until post-mortem³.

AccurKardia’s novel AI technology is designed to address these challenges by offering a practical solution that complements a readily available diagnostic test, the ECG, for identifying at-risk patients earlier and more efficiently. This solution will be particularly impactful in underserved regions where cardiology specialists and advanced imaging is not readily available. Additionally, by enabling earlier detection and intervention, the software has the potential to help save payers millions in healthcare costs while optimizing resource use and enhancing the sustainability of healthcare services.

“Our mission is to improve patient outcomes and save lives by transforming ECG into a broad biomarker, with initial focus in cardiology,” said Juan C. Jimenez, co-Founder and CEO of AccurKardia. “Our AVS detection technology is the first application of its kind in the detection of structural heart disease, where the condition is chronically underdiagnosed, has a high mortality rate, and can otherwise be treated successfully. Not only will patients benefit from improved outcomes, but payers will benefit from reduced costs, particularly from fewer heart failure hospitalizations. Hospitals systems that adopt it could also benefit from improved utilization of their Heart Teams.”

For a diagnostic tool to qualify for FDA Breakthrough Device Designation, it must provide more effective diagnosis of life-threatening conditions, represent a breakthrough in technology, and offer significant advantages over existing alternatives. For AccurKardia’s AVS screening software, the designation grants the company accelerated interactions with FDA review teams, prioritized review, and special reimbursement consideration to facilitate expedited commercialization for patients in need.

About AccurKardia

AccurKardia is an ECG-led diagnostics software company focused on transforming ECG data into a powerful biomarker to improve patient outcomes and save lives globally. With initial applications in cardiology, the company offers transformative, cloud-based diagnostic tools, including AccurECG™⁴, an FDA-cleared Class II software as a medical device (SaMD) for fully automated, near real-time ECG interpretation. Currently, AccurKardia is part of the 2024 Cohort of MedTech Innovator (MTI) and one of five companies in the American Heart Association’s Heart and Brain Health Accelerator track within MTI. For more information, please visit www.accurkardia.com.

References

Leon, M.B., Smith, C.R., Mack, M., et al; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607.
Sethi, A., Elmariah, S., Gunnarson, C., et al. The cost of waiting for a transcatheter aortic valve replacement (TAVR) in medicare beneficiaries with severe aortic stenosis. Structural Heart (2024).
Das, P., Pocock, C., Chambers, J. The patient with a systolic murmur: severe aortic stenosis may be missed during cardiovascular examination. QJM 2000 Oct;93(10):685-8.
Refer to US FDA 510(k) K223013 Indications for Use and product labeling for technical requirements and relevant disclosures