CorVista Health’s System Gains Breakthrough Device Designation

The FDA has granted Breakthrough Device designation to CorVista Health’s CorVista System, a non-invasive diagnostic test for patients with suspected pulmonary hypertension (PH), a type of high blood pressure that affects the arteries in the lungs and the heart.

The point-of-care test collects cardiac and hemodynamic signals and uses machine learning to identify patients with PH earlier, as the condition often presents with symptoms similar to coronary artery disease and heart failure.

CorVista Health conducted prospective clinical studies of patients with and without PH, and applied novel machine learning techniques to show that the system is likely to improve the current standard of care.