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

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