ECG-AI™ LEF Indications for Use

The ECG-AI LEF 12-Lead algorithm is software intended to aid in earlier detection of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% in adults at risk for heart failure. This population includes, but is not limited to:

• patients with cardiomyopathies
• patients who are post-myocardial infarction
• patients with aortic stenosis
• patients with chronic atrial fibrillation
• patients receiving pharmaceutical therapies that are cardiotoxic, and
• postpartum women.

The ECG-AI LEF 12-Lead algorithm is not intended to be a stand-alone diagnostic device for cardiac conditions, should not be used for monitoring of patients, and should not be used on ECGs with a paced rhythm.

A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. Additionally, if the patient is at high risk for the cardiac condition, a negative result should not rule out further non-invasive evaluation.

The ECG-AI LEF 12-Lead Algorithm should be applied jointly with clinician judgment.