Anumana Receives the US FDA’s Clearance for ECG-AI Algorithm to Detect Low Ejection Fraction
- The company received the US FDA clearance for ECG-AI LEF, its new artificial intelligence (AI) model that identifies signs of low ejection fraction (LEF) in patients at risk of heart failure. The ECG-AI LEF algorithm was developed as part of a collaboration with the Mayo Clinic
- The (EAGLE) study conducted by Mayo Clinic showed that the AI algorithm improved diagnosis of low EF by 31% over SoC without increasing the overall rate of echocardiogram usage
- The AI model was validated in a clinical trial involving 16000 patients and showed a sensitivity of 84.5% and specificity of 83.6%. ECG-AI LEF achieved an AUROC7 of 0.932 demonstrating an ability to differentiate b/w LEF and EF >40%
Ref: Businesswire | Image: Pfizer
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