FDA grants AI-powered ECG screening tool for aortic stenosis its breakthrough device designation
AccurKardia, a New York-based healthcare technology company, has received the FDA’s breakthrough device designation for new screening software that uses artificial intelligence (AI) to evaluate electrocardiogram (ECG) data for signs of aortic stenosis (AS).
The software was trained on millions of ECGs, according to AccurKardia, and was designed to provide insights in underserved parts of the world where more advanced imaging modalities are not readily available.
“Our mission is to improve patient outcomes and save lives by transforming ECG into a broad biomarker, with initial focus in cardiology,” Juan C. Jimenez, co-founder and CEO of AccurKardia, said in a statement. “Our AS 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.”
“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,” added Eduardo Hernandez, MD, 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 aortic valve stenosis in elderly patients.”
The FDA’s breakthrough devices program is designed to help medical devices make it through the approval process faster than they would otherwise. The agency’s representatives work directly with the device manufacturer, for example, and any submissions related to the device will be prioritized.
This software is not yet approved by the FDA.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.