CorVista Health is a digital health company that offers the CorVista System, a non-invasive point-of-care solution for evaluating the presence of cardiovascular diseases. The system utilizes machine learning algorithms to analyze a patient's cardiac and hemodynamic signals, enabling the prediction of conditions like coronary artery disease (CAD), pulmonary hypertension, and elevated left ventricular end-diastolic pressure (LVEDP) without the need for radiation, contrast agents, injections, fasting, or exercise.
The CorVista System has received FDA clearance for its CAD Add-On, designed to detect significant CAD. In a clinical validation study, the CAD Add-On demonstrated a sensitivity of 88% and a specificity of 51% in diagnosing severe CAD, with a negative predictive value of 99%. This performance is comparable to coronary computed tomography angiography (CCTA).
Additionally, CorVista Health has developed algorithms for detecting pulmonary hypertension and elevated LVEDP, a key indicator of heart failure. The pulmonary hypertension algorithm received FDA Breakthrough Designation, while the LVEDP algorithm exhibited a sensitivity of 82% and a specificity of 68% in predicting elevated LVEDP levels in a study published in PLOS ONE.
The CorVista System aims to provide rapid and accessible cardiovascular diagnostics, particularly in rural and underserved areas where access to specialized equipment and personnel may be limited. The company emphasizes the potential of its technology to enable more equitable care by delivering actionable results at the point of care.
In September 2023, CorVista Health (previously known as Analytics four Life) announced the acquisition of FDA clearance for the CorVista System with the CAD Add-On.
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