AccurKardia’s Aortic Stenosis AI Screening Software Receives FDA Breakthrough Device Designation

October 8, 2024—AccurKardia announced that its aortic stenosis (AS) electrocardiogram (ECG)–based artificial intelligence (AI) screening software has been granted Breakthrough Device designation by the FDA.

According to the company, its AS screening software aims to leverage the ubiquity of the ECG to identify potential cases of AS within millions of ECGs already present in health care system electronic health records. The screening software will help identify and prioritize which patients should receive ECGs for definitive diagnosis.

“AccurKardia’s recent advancement has the potential to create a paradigm shift in the detection of AS, where earlier detection and treatment may mean the difference between life or death,” commented Eduardo Hernandez, MD, in the company’s press release.

Dr. Hernandez, President of The Texas Heart Institute Center for Cardiovascular Care in Houston, Texas, continued, “Once FDA cleared and successfully deployed, this technology could become established as a standard-of-care screening tool for AS in elderly patients.”

In the press release, AccurKardia stated that up to 50% of AS cases are not discovered until postmortem. The substantial impact of underdiagnosing AS includes a mortality rate as high as 50% within 1 year in untreated AS and approximately $10,000 in increased health care expenses per patient per year versus treated cases.

The company further noted that detection of AS in many patients is missed by current practice for a variety of reasons. These include poor symptom recognition by the elderly, the lack of murmur in some cases, the time-constrained environment of primary care visits, and limited access to ECG.

AccurKardia’s AI technology is designed to complement ECG to identify at-risk patients earlier and more efficiently. The company stated that this solution will be particularly impactful in underserved regions where cardiology specialists and advanced imaging are not readily available.

By enabling earlier detection and intervention, the software has the potential to help save millions in health care costs while optimizing resource use and enhancing the sustainability of health care services, advised the company.