CorVista Device to Diagnose PH Gets FDA Breakthrough Designation

Point-of-care diagnostic device to use non-invasive tests, machine learning

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Food and Drug Administration (FDA) granted breakthrough device designation to the CorVista System, a point-of-care diagnostic tool that aims to use non-invasive tests and machine learning to help diagnose pulmonary hypertension and other cardiovascular disorders.

The designation gives CorVista Health, the system’s developer, certain benefits aimed at speeding the device’s development and potential approval. These include chances for more frequent meetings with the FDA during the development process and priority review for future regulatory submissions.

This status is given to devices with the potential to improve care for serious diseases.

“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,” Don Crawford, president and CEO of CorVista, said in a press release.

“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,” Crawford said.

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Diagnosing pulmonary hypertension is often a lengthy process that involves numerous medical tests. Delays in getting a correct diagnosis usually mean delays in getting the right care, ultimately translating to worse outcomes for patients.

The CorVista System is a point-of-care test, meaning it is performed and results are available in a single visit with a clinician. It also does not require radiation, contrast agents, injections, fasting, or exercise.

That means that the system “has potential to enable more equitable care by providing access to immediately actionable, high quality cardiovascular status results in low-resource settings, where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available,” according to CorVista.

It could help to “advance the quality of care in rural and disadvantaged urban settings,” the company stated.

The system works by measuring cardiac and hemodynamic (blood flow) signals from a patient on a simple, hand-held digital device. As this data is acquired, it is analyzed using machine learning — put simply, computers use complex mathematical algorithms to sort through the signals and help determine a diagnosis.

Results of the test are made available to the treating clinician within minutes, according to CorVista. In addition to the add-on to detect pulmonary hypertension, the device is also being developed to detect other cardiovascular conditions.

“Unfortunately, there have not been any meaningful advancements to facilitate the early diagnosis of pulmonary hypertension in decades,” said Vallerie McLaughlin, MD, a professor at the University of Michigan and medical advisory board member at CorVista.

“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,” McLaughlin said.

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