FDA grants breakthrough device designation to AI-powered aortic stenosis screening tool
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Key takeaways:
- The FDA granted breakthrough device designation to AccurKardia’s AI-powered aortic valve stenosis screening software.
- The algorithm is designed to identify aortic stenosis from ECGs stored in the EHR.
AccurKardia announced its AI-powered, ECG-based aortic valve stenosis screening software has been granted breakthrough device designation by the FDA.
The screening software is designed to identify patients with potential aortic valve stenosis from the millions of ECGs already stored in a center’s EHR system, according to a company press release.
The breakthrough device designation is intended to expedite the development and review of devices intended to treat a serious condition in which preliminary clinical evidence indicates potentially substantial improvement over available devices.
Aortic valve stenosis is typically diagnosed via bedside examination, auscultation and echocardiography, but patients may be missed due to poor symptom recognition by the elderly, lack of murmur, limited access to echocardiography and more, according to the 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,” Eduardo Hernandez, MD, president of The Texas Heart Institute Center for Cardiovascular Care, said in the release. “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.”
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