The diagnostic software for aortic valve stenosis has received FDA Breakthrough Device Designation, aiming to improve early detection through ECG analysis in healthcare settings.
Summary: AccurKardia, a diagnostics software company, has been granted FDA Breakthrough Device Designation for its aortic valve stenosis (AVS) ECG-based AI screening software. The software is designed to detect potential cases of AVS by analyzing millions of existing ECGs in healthcare systems, enabling earlier identification of at-risk patients who may benefit from echocardiograms for a definitive diagnosis. This AI tool aims to address the challenge of underdiagnosed AVS, a condition that is life-threatening if not treated early, particularly in elderly patients. With this designation, AccurKardia will have accelerated FDA review, potentially improving patient outcomes and reducing healthcare costs.
Key Takeaways:
- FDA Breakthrough Designation: AccurKardia’s AVS screening software received FDA Breakthrough Device Designation for using ECG-based AI to identify aortic valve stenosis.
- Early Detection Focus: The software leverages ECGs already present in electronic health records to detect potential AVS cases, aiming to address the underdiagnosis of this life-threatening condition.
- Impact on Healthcare: By facilitating earlier diagnosis and intervention, the AI tool could reduce mortality rates and healthcare costs, especially in underserved regions where advanced imaging is less accessible.
AccurKardia, an ECG-led diagnostics software company, announced that its aortic valve stenosis (AVS) ECG-based AI screening software has been granted Breakthrough Device Designation by the US 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,” says Eduardo Hernandez, MD, president of The Texas Heart Institute Center for Cardiovascular Care, in a release. “Once FDA-cleared and successfully deployed, this technology could become established as a standard-of-care screening tool for AVS in elderly patients.”
Gaps in Current Practice
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% within one year, and untreated cases result in approximately $10,000 in increased healthcare expenses per patient per year versus treated cases. Yet up to 50% of AVS cases are missed until post-mortem.
Complementing the ECG for Identifying At-Risk Patient
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. The company says 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,” says Juan C. Jimenez, co-founder and CEO of AccurKardia, in a release. “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. Hospital 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.
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