Low Ejection Fraction AI-ECG Algorithm
Anumana, Inc.The Low Ejection Fraction AI-ECG Algorithm by Anumana, Inc. is a software tool that analyzes 12-lead ECG signals using AI to aid in screening for patients with low left ventricular ejection fraction (≤ 40%). It helps clinicians identify adults at risk of heart failure to decide if further cardiac evaluation is needed. It works quickly on routine ECGs and does not replace diagnostic imaging but supports clinical judgment.
Intended Use
Software intended to aid in screening for Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% in adults at risk for heart failure.
Technology
A software-based AI algorithm analyzing 10 seconds of 12-lead ECG voltage time series data. Delivered as a software module integrated with third-party medical software, providing a prediction of low LVEF to clinician systems.
Performance
The algorithm was trained on over 93,000 patients with paired ECG and echocardiogram measurements. Clinical validation on 16,000 patients from 4 US health systems showed sensitivity and specificity above 80% for detecting LVEF ≤ 40%, with subgroup analyses supporting consistency across demographics and ECG devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/5/2023
23 days - 2
FDA Approval
9/28/2023
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