Tempus ECG-PH is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with a patient having elevated mean pulmonary artery pressure (mPAP > 20 mmHg), an indicator of pulmonary hypertension (PH). It is for use on clinical diagnostic 12-lead ECG recordings collected at a healthcare facility from patients 40 years of age or older with cardiovascular symptoms (dyspnea, fatigue, chest pain, or edema), who do not have a known history of PH. Tempus ECG-PH only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-PH is not intended to be a stand- alone diagnostic tool for PH, should not be used for serial patient monitoring, and should not be used on ECGs with paced rhythms. Results should always be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings, as well as the patient’s symptoms, other tests, and clinical history.
A software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.
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