FDA Clears CorVista® System with Pulmonary Hypertension Add-On, Revolutionizing Point-of-Care Cardiovascular Testing

Saturday, April 06, 2024

Analytics for Life and CorVista Health have announced FDA clearance for the CorVista System with the Pulmonary Hypertension (PH) Add-On Module. This groundbreaking technology marks the first FDA-cleared, machine-learned point-of-care solution designed to assess the likelihood of elevated mean arterial pulmonary pressure (mPAP), a key indicator of pulmonary hypertension (PH). PH is a progressive disorder affecting lung blood vessels, placing strain on the heart's efforts to supply blood to the area. Approximately 1% of the global population is impacted by PH, and over half of heart failure patients may be affected, particularly those with limited access to advanced cardiovascular care.

Despite diagnostic advancements, PH diagnosis remains challenging due to symptom overlap with other cardiac and pulmonary conditions. Limited early detection and treatment options contribute to increasing PH-related mortality rates, underscoring the urgency for diagnostic innovation.

The CorVista System with PH Add-On addresses this critical need, poised to enable earlier diagnosis and improve patient outcomes in PH detection and treatment. FDA's breakthrough designation follows a pilot performance study indicating enhanced PH diagnosis within standard care. Extensive clinical validation (IDENTIFY PH) demonstrated the system's algorithm achieving 82% sensitivity, 92% specificity, and a negative predictive value (NPV) exceeding 99%.

Integration of the PH indication into the CorVista System empowers healthcare providers to non-invasively test symptomatic patients for multiple cardiovascular conditions in a single procedure at the point-of-care. With market clearance achieved, the CorVista System with PH Add-On joins a select group of under 100 breakthrough-designated devices entering the US market.


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