AccurKardia has announced that its aortic valve stenosis electrocardiogram (ECG)-based artificial intelligence (AI) screening software has been granted breakthrough device designation by the US Food and Drug Administration (FDA).
The screening software aims to leverage the ubiquity of the ECG to identify potential cases of aortic stenosis within millions of ECGs already present in healthcare system electronic health records in order to help identify and prioritise which patients should receive echocardiograms for definitive diagnosis, AccurKardia says in a press release.
“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, 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 aortic valve stenosis in elderly patients.”
AccurKardia’s novel AI technology is designed to address challenges in the detection and diagnosis of aortic stenosis 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’s press release adds.
“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 aortic valve stenosis 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 hospitalisations. Hospitals systems that adopt it could also benefit from improved utilisation of their Heart Teams.”
