The Food and Drug Administration (FDA) has granted 510(k) clearance to EchoGo® Amyloidosis, an artificial intelligence (AI) software developed by Ultromics, designed to improve the early detection of cardiac amyloidosis, a condition frequently missed in high-risk patients with heart failure and preserved ejection fraction (HFpEF). This clearance marks a significant advancement in diagnostic tools available to clinicians.
Requiring only a single apical four-chamber echocardiography video clip, the EchoGo® Amyloidosis software aims to enhance the accuracy of cardiac amyloidosis detection. Ultromics reports that the AI software has demonstrated 84.5% sensitivity and 89.7% specificity in diagnosing cardiac amyloidosis in patients with heart failure aged 65 years and older, according to research submitted to the FDA.
The AI software has shown consistent sensitivity rates across various subtypes of amyloidosis. Specifically, it demonstrated 84.4% sensitivity for AL (primary) amyloidosis, 86.3% for hereditary transthyretin amyloidosis (TTRv), and 85.8% for wild-type transthyretin amyloidosis.
Clinical Impact and Expert Opinion
Sanjiv J. Shah, M.D., Director of the Heart Failure with Preserved Ejection Fraction (HFpEF) Program and the Center for Deep Phenotyping and Precision Medicine at Northwestern University Feinberg School of Medicine, emphasized the importance of early detection. "Improving the detection of cardiac amyloidosis is vital as early detection provides the greatest therapeutic benefit for patients. Novel AI-based diagnostic tools such as EchoGo® Amyloidosis from Ultromics should help facilitate disease identification, particularly in clinics and hospitals restricted by expertise and resource," said Shah.
