ECG-AI™ Pulmonary Hypertension Indications for Use

The ECG-AI PH 12-Lead algorithm is software intended to aid in earlier detection of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension, in adults presenting with dyspnea. ECG-AI PH 12-Lead algorithm is not intended to be a stand-alone diagnostic device for pulmonary hypertension or replace current clinical practice guidelines.

A positive result may suggest the need for further clinical evaluation. Additionally, if the patient is at high risk for pulmonary hypertension, a negative result should not rule out additional clinical evaluation.

ECG-AI PH 12-Lead algorithm should be applied jointly with clinician judgment.

ECG-AI PH 12-Lead algorithm should not be used on ECGs from adults with an implanted pacemaker or on ECGs with a paced rhythm.