CorVista System with Pulmonary Hypertension Add-On Cleared by FDA

Analytics for Life Inc. and CorVista Health Inc. have received U.S. Food and Drug Administration (FDA) clearance of the CorVista System with Pulmonary Hypertension (PH) Add-On Module. The CorVista System is reportedly the first FDA-cleared, machine learned point-of-care technology for indicating the likelihood of elevated mean arterial pulmonary pressure (mPAP), an indicator of pulmonary hypertension (PH).
 
Pulmonary hypertension is a progressive disorder that affects the lung’s blood vessels, causing the heart to work harder to deliver blood to the area. PH affects approximately 1% of the global population, and more than half of heart failure patients may be affected—the vast majority (80%) of whom live in areas with limited access to advanced cardiovascular medical and surgical care. Despite advances in diagnostic technologies, PH is still often difficult to diagnose due to overlapping symptoms with other heart and lung conditions. Limited early detection and existing treatment options have contributed to increasing mortality rates for people living with PH, highlighting the need for continued diagnostic innovation. The CorVista System with PH Add-On responds to this need, positioned to enable earlier diagnosis and better patient experiences in PH detection and treatment.

“As we continue to expand the CorVista System, we are proud to deliver advancements in diagnostics that support the earlier-stage detection of serious conditions, such as PH and CAD,” CorVista Health Vice President and General Manager Ian Shadforth said. “Through CorVista, we are seeing how the power of machine learning can revolutionize care pathways, enabling earlier-stage detection and diagnosis, and ultimately empowering clinicians to deliver improved care and long-term outcomes.”
 
The non-invasive CorVista System was recently cleared for use in evaluating the presence of significant coronary artery disease. In 2022 the FDA designated the CorVista System with PH Add-On as a Breakthrough Device for its potential to improve PH diagnosis. The breakthrough designation followed FDA’s review of a pilot performance study that demonstrated a reasonable expectation for the device to provide more effective diagnosis of PH in the standard of care. Results of the extensive clinical validation study supporting the market application (IDENTIFY PH) showed algorithm performance in identifying patients with elevated mPAP with 82% sensitivity and 92% specificity with a >99% negative predictive value (NPV). Introduction of the PH indication to the CorVista System will allow healthcare providers to test symptomatic patients for multiple significant cardiovascular conditions in a single non-invasive procedure at the initial point of care. Having received market clearance, the CorVista System with PH Add-On joins a small cohort of less than 100 breakthrough-designated devices to enter the U.S. market. 
 
“Through the CorVista System, we have harnessed the potential of machine learning to develop our detection algorithms and deliver precise and reliable diagnostic tools,” Analytics for Life Chief Technology Officer/General Manager Jonathan Woodward stated. “The Pulmonary Hypertension Add-On underscores our dedication to advancing solutions that make a tangible difference in patients’ lives.”

Analytics For Life will continue to partner with CorVista Health to commercialize the CorVista System within the United States. 
 
“I can’t emphasize the importance of early diagnosis enough,” said Vallerie V. McLaughlin, M.D., the Kim A. Eagle M.D. Endowed Professor of Cardiovascular Medicine, director of Pulmonary Hypertension at the University of Michigan Ann Arbor, and CorVista Health Medical Advisory Board member. “This technology has the potential to really improve the time from symptoms to diagnosis.”
 
Pulmonary hypertension is challenging to diagnose, affecting an estimated 1% of the world population and up to 10% of people greater than 65 years of age as well as 50% of patients with heart failure. The vast majority of those persons with this disorder (80%) live in areas with limited access to appropriate medical and surgical care. Pulmonary arterial hypertension is an aggressive disease resulting in right ventricular pressure/volume overload, right ventricular failure, and, in many cases, early death.
 
The CorVista System is a prescription only, non-invasive point-of-care solution intended to synchronously collect and apply machine learning to a symptomatic patient’s cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting, or exercise. Within minutes of the test, the CorVista Analysis is available in a secure web portal to help physicians diagnose and treat patients with suspected cardiovascular disease. The CorVista System is developed and manufactured by Analytics For Life Inc. and licensed to CorVista Health Inc.
 
Headquartered in Toronto, Analytics For Life specializes in non-invasive diagnostic solutions for cardiovascular diseases through the CorVista System. The CorVista System offers a non-invasive, point-of-care solution to assess symptomatic patients for cardiovascular disease without radiation, contrast agents, injections, fasting, or exercise. 
 
CorVista Health Inc. is applying machine learning to deliver cardiac disease detection algorithms using the proprietary CorVista System platform to transform cardiovascular care and the patient experience.