Anumana Receives FDA Clearance for ECG-AI LEF to Detect Low Ejection Fraction

Anumana has received U.S. FDA 510(k) clearance for ECG-AI LEF, an innovative software-as-a-medical device (SaMD) designed to screen for Low Ejection Fraction (LEF) in adults at risk for heart failure using data from a routine 12-lead electrocardiogram (ECG).

Based on groundbreaking research from the Mayo Clinic, the algorithm was developed using more than 100,000 ECG and echocardiogram data pairs from individual patients and has been clinically tested in more than 25 studies involving more than 40,000 patients in the US and internationally.

Anumana is focused on rapid adoption of the new ECG-AI category, clinical development and commercialization of its novel healthcare technologies. The newly FDA cleared ECG-AI LEF can be easily integrated into various ECG information management systems or directly into a patient’s electronic health record via Anumana’s web-based ECG viewer to support clinical decision making.

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