CorVista Health Receives Breakthrough Device Designation for The CorVista® System

Wednesday, October 26, 2022

CorVista Health, Inc, a digital health company dedicated to improving cardiovascular disease diagnosis, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CorVista System as a first non-invasive point of care diagnostic solution for patients with suspected pulmonary hypertension.

The FDA’s Breakthrough Devices Program is a voluntary program available to therapeutic devices that establish they have the potential to provide more effective treatment or diagnosis of life threatening or irreversibly debilitating diseases or conditions. Breakthrough designation provides several important benefits, including prioritized review of future regulatory submissions and greater opportunity to interact with FDA experts throughout the review process.

“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 President and CEO Don Crawford. “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.”

The CorVista System offers two important improvements to the current standard of care for diagnosing pulmonary hypertension – expansion of the population for use of a non-invasive, point-of-care test and potential for significant reduction in time to diagnosis and treatments thereby allowing improved patient outcomes. The CorVista System Breakthrough Device Designation was supported by prospective clinical studies which allow for a highly accurate labeling of subjects with and without the disease of interest, and the application of novel machine learning techniques which have provided clear evidence the system is likely to improve the current standard of care.

“Unfortunately, there have not been any meaningful advancements to facilitate the early diagnosis of pulmonary hypertension in decades,” said Vallerie V McLaughlin, M.D. Kim A Eagle MD Endowed Professor of Cardiovascular Medicine and Director Pulmonary Hypertension at the University of Michigan Ann Arbor and CorVista Health Medical Advisory Board member. “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.”

Importantly, a critical impediment to correctly diagnosing PH patients results from their frequent presentation with symptoms similar to other common cardiovascular disease states such as, coronary artery disease and heart failure, further increasing the complexity of its recognition and ultimately diagnosis. The CorVista System with its novel PH Add-On is intended to indicate the likelihood of elevated mean pulmonary arterial pressure at point-of-care so that by identifying patients with PH earlier in the clinical pathway, patient care can be better triaged, and treatment outcomes can be maximized by patient type and need.

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