AccurKardia announced that it received FDA breakthrough device designation for its aortic valve stenosis (AVS) ECG-based AI screening software.
New York-based AccurKardia’s AVS screening software aims to leverage ECG to identify potential cases of AVS within millions of ECGs already present in healthcare system electronic health records. It aims to identify and prioritize which patients should receive echocardiograms for definitive diagnosis.
Last year, the company won FDA clearance for its cloud-based ECG interpretation software.
AccurKardia’s latest breakthrough technology addresses the challenges of identifying AVS with a practical solution that complements a readily available diagnostic test in the ECG. This helps to identify at-risk patients earlier and more efficiently. AccurKardia says the solution could particularly prove useful in underserved regions without readily available cardiology specialists and advanced imaging.
Additionally, the company says enabling earlier detection and intervention could help save payers millions in healthcare costs. Meanwhile, it could also optimize resource use and enhance 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.”
