Emerging ECG-Based AI Screening Software for Aortic Valve Stenosis Gets FDA’s Breakthrough Device Designation
With the capability of identifying possible cases of aortic value stenosis (AVS) from existing electrocardiograms (ECGs), the AI-powered screening software from AccurKardia may facilitate earlier diagnosis of AVS, which is fatally missed in 50 percent of patient who have this condition.
The Food and Drug Administration (FDA) has issued its Breakthrough Device Designation for screening software that utilizes artificial intelligence (AI) assessment of existing electrocardiograms (ECGs) to identify patients who may have aortic valve stenosis (AVS).1
Estimated one-year mortality rates can be as high as 50 percent for undetected AVS, according to AccurKardia, the developer of the software.2 However, the company noted the AVS screening software is able to identify patients at risk of AVS through a review of existing ECGs in a patient’s electronic health record. The screening software subsequently flags patients for a follow-up ECG to confirm the AVS diagnosis, according to AccurKardia.
“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 Eduardo Hernandez, M.D., president of the Texas Heart Institute Center for Cardiovascular Care in Houston. “Once FDA-cleared and successfully deployed, this technology could become established as a standard-of-care screening tool for AVS in elderly patients.”
Through earlier detection and intervention for AVS, AccurKardia suggests the AI-powered screening software could also reduce heart failure hospitalizations and potentially save millions in health-care costs.
References
1. AccurKardia. AccurKardia receives FDA breakthrough device designation for first-of-its-kind aortic valve stenosis ECG-based AI screening software. Available at: https://www.businesswire.com/news/home/20241008099886/en/AccurKardia-Receives-FDA-Breakthrough-Device-Designation-for-First-of-its-Kind-Aortic-Valve-Stenosis-ECG-based-AI-Screening-Software . Published October 8, 2024. Accessed October 8, 2024.
2. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607.
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