The CorVista® System, an innovative noninvasive point-of-care solution for patients with suspected pulmonary hypertension, has received breakthrough device designation from the US Food and Drug Administration (FDA).

This new technology may add value to the diagnosis of pulmonary arterial hypertension (PAH).

“We’re very pleased for the opportunity to continue to work closely with the FDA to fulfill our mission to improve the diagnosis and treatment of cardiovascular diseases and importantly our solution for pulmonary hypertension for which the Breakthrough Designation was awarded,” said Don Crawford, president and CEO of CorVista® Health. “While the CorVista System is not yet FDA cleared, we are hopeful that Breakthrough Device Designation will help expedite patient access to the CorVista System as a non-invasive point of care diagnostic solution.”

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The CorVista System analyzes a patient’s cardiac and hemodynamic signals through a machine learning algorithm to predict the likelihood of cardiovascular disease. The process does not require radiation, contrast agents, injections, fasting, or exercise as opposed to conventional diagnostic methods. The results are available within a few minutes in a secure web portal that can be accessed by physicians to aid early diagnosis.

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In this way, the CorVista System provides 2 important advantages over currently used approaches: it should serve a larger population as it is a noninvasive, point-of-care test, and it decreases the time to diagnosis and treatments, which could improve clinical outcomes.

Vallerie V. McLaughlin, MD, a member of the CorVista Health Medical Advisory Board, recognizes the difficulties in early diagnosis of pulmonary hypertension. “Unfortunately, there have not been any meaningful advancements to facilitate the early diagnosis of pulmonary hypertension in decades,” she said. “I am hopeful the non-invasive CorVista System will enable clinicians to diagnose patients suffering from pulmonary hypertension at an earlier stage, ultimately improving patient care and outcomes.”


CorVista Health receives breakthrough device designation for the CorVista® System. News release. CorVista Health, Inc.; October 25, 2022.