AccurKardia has been granted breakthrough device designation from the U.S. Food and Drug Administration for its aortic valve stenosis (AVS) ECG-based AI screening software.
 
The company’s AVS screening software uses the ubiquity of the electrocardiogram (ECG) to spot potential AVS cases within millions of ECGs already present in healthcare system electronic health records (EHRs). This can help identify and prioritize which patients should undergo echocardiograms for definitive diagnosis.
 
AccurKardia believes the solution will be particularly impactful in underserved regions where cardiology specialists and advanced imaging aren’t readily available. The company also hopes by allowing earlier detection and intervention that the software could save payers millions in healthcare costs, while optimizing resource use and enhancing 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.”

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“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.”