Study achieves primary sensitivity endpoint, advancing diagnostics for heart failure with preserved ejection fraction (HFpEF) and pulmonary hypertension (PH)Results build on data previously presented at ACC.25 in March 2025 TORONTO and BETHESDA, Md., Aug. 14, 2025 (GLOBE NEWSWIRE) — Analytics For Life, in collaboration with its U.S. commercial partner CorVista Health, today announced the successful completion of the clinical study evaluating a machine learning-based algorithm for non-invasively identifying patients with elevated pulmonary capillary wedge pressure (PCWP) – a key indicator of both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF). The study met its primary endpoint for sensitivity, marking a significant milestone in the advancement in point-of-care diagnostics for heart failure patients. The results of the study will be submitted for peer-reviewed publication and presented at an upcoming scientific conference. Currently, PCWP is measured through an invasive right heart catheterization (iRHC) procedure, typically performed by a cardiologist, pulmonologist or intensivist. The CorVista capture device collects non-invasive signals for 3.5 minutes in patients at rest, potentially providing a novel method to aid in the assessment of patients being evaluated for pulmonary hypertension or heart failure. “Reaching our primary endpoint in sensitivity is a testament to the dedication of our team to pushing the boundaries of cardiovascular diagnostics. Our ability to deliver non-invasive, rapid assessment of PCWP could be a game-changer, making early detection of HFpEF, HFrEF and PH subtypes more accessible for patients,” said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer, Analytics for Life and CorVista Health. “With the clinical study now complete, we plan to initiate dialogue with regulatory agencies in preparation for the next phase of development.” Adrian Lam, President and Chief Executive Officer, CorVista Health, added, “This milestone demonstrates the power of our rapid, point-of-care solution and represents an important step toward expanding the clinical utility of the CorVista System. Adding PCWP and heart failure capabilities would allow our system to provide diagnostic support to more than 70% of all people with symptomatic cardiovascular disease – itself the leading cause of death worldwide. As we pursue a PCWP add-on, our goal is to bring advanced diagnostic accuracy into the primary care setting, enabling faster and more accurate treatment decisions while reducing the overall cost of care.” HFpEF accounts for over 50% of all heart failure cases and carries the highest rates of morbidity and mortality. Underdiagnosis of HFpEF remains one of the greatest unmet needs in cardiovascular medicine today, contributing an estimated $25 billion in direct costs to the U.S. healthcare system each year. Pulmonary hypertension, similarly underdiagnosed, requires accurate subtype classification to guide life-saving, guideline-directed therapy. The proposed PCWP add-on represents a major advancement in cardiology with far-reaching implications for early diagnosis, equitable care, and cost reduction. The CorVista System Add-On for elevated PCWP is currently an investigational device, limited by U.S. federal law to investigational use and not commercially available. About CorVista System® Developed by Analytics For Life and commercialized in the U.S. by CorVista Health, the CorVista System is a point-of-care digital health solution that detects multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze heart signals and detect issues like blocked arteries or elevated pulmonary artery pressure—all in under 30 minutes, allowing clinicians to interpret results and guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension in April 2024, with additional indications, including heart failure, in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking the first major advancement in PH diagnostics in over 40 years and setting a new standard for patient care. About Analytics For Life Analytics 4 Life stands at the forefront of digital health, dedicated to propelling next-generation technologies that revolutionize point-of-care diagnostics. Headquartered in Toronto, Canada, Analytics For Life specializes in pioneering non-invasive diagnostic solutions for cardiovascular diseases through the CorVista System®. The innovative CorVista System offers a non-invasive, point-of-care solution enabling physicians to assess symptomatic patients for cardiovascular disease without radiation, contrast agents, injections, fasting, or exercise. Spearheading its introduction in the United States is our exclusive commercial partner, CorVista Health. For more information on Analytics For Life, please visit: www.analytics4life.com About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care. For more information on CorVista Health, please visit: www.corvista.com Media Contact:media@corvista.com
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CorVista Health Announces European Respiratory Journal Publication Detailing Validation of its Non-Invasive Test for Pulmonary Hypertension
Data demonstrates CorVista’s proprietary machine-learned algorithm detects elevated mean pulmonary artery pressure (mPAP) with strong sensitivity and specificity across diverse patient populations BETHESDA, Md., May 07, 2025 (GLOBE NEWSWIRE) — CorVista Health today announced the publication of data in European Respiratory Journal (ERJ) Open Research, a leading peer-reviewed journal. The study validates CorVista’s machine learned, non-invasive algorithm for aiding in the diagnosis of pulmonary hypertension (PH) using signals collected by the CorVista System®, the world’s first non-invasive point-of-care solution for evaluating both coronary artery disease and pulmonary hypertension. The published article, titled “Clinical validation of a machine-learned, point-of-care system to IDENTIFY pulmonary hypertension,” provides compelling evidence that the CorVista System can accurately detect elevated mean pulmonary artery pressure (mPAP) – a hallmark of PH – with diagnostic performance comparable to, or surpassing, current standard-of-care modalities. “Pulmonary hypertension remains vastly underdiagnosed, with patients waiting an average of two and a half years from symptom onset to accurate diagnosis—often after disease progression has already compromised outcomes,” said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer, CorVista Health. “The findings published in ERJ Open Research demonstrate the clinical power of our machine-learned, non-invasive test to identify PH in just minutes at point of care. The CorVista System can transform our approach to PH diagnosis as a frontline diagnostic tool. Now that highly effective new treatment options exist for most patients with PH, earlier detection has become critically important.” Currently, PH is primarily diagnosed through right heart catheterization (RHC), an invasive and resource-intensive procedure. Transthoracic echocardiography (TTE), while commonly used as a screening tool, can have significant limitations – particularly the inability to measure tricuspid regurgitant velocity in up to 41% of patients. The CorVista System offers a non-invasive, stress-free test option conducted in under five minutes, making it a powerful tool to address the critical unmet need for earlier and broader diagnosis of PH. Key findings from the publication include: The algorithm achieved 82% sensitivity and 92% specificity for detecting mPAP ≥25 mmHg (95% CI: 0.78–0.87 and 0.87–0.96, respectively), meeting the study’s pre-specified primary endpoints.Performance remained high at the updated PH threshold of mPAP ≥21 mmHg, with 78% sensitivity and 92% specificity.ROC-AUC was 0.95 and 0.93 at the 25 mmHg and 21 mmHg thresholds, respectively.Diagnostic accuracy was consistent across PH subtypes (pre-capillary, combined pre-/post-capillary, and isolated post-capillary), as well as across sex, age, BMI, and key comorbidities such as diabetes and COPD.Negative predictive value (NPV): > 99%. The study enrolled 462 symptomatic patients across 18 U.S. clinical sites and was conducted under a rigorous, blinded design. Patients underwent signal acquisition using the CorVista System prior to RHC or – in PH-negative controls – to CT angiography and echocardiography. Importantly, the system’s performance was validated using a dataset independent of the one used in algorithm development, supporting its real-world applicability and generalizability. About CorVista System® The CorVista System is a point-of -care digital health solution that can aid in diagnosis of multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze physiological signals and detect signs of serious cardiovascular diseases – all in under 30 minutes, allowing clinicians to interpret results and help guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension in April 2024, with additional indications, including Pulmonary Capillary Wedge Pressure (PCWP), in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking a major advancement in PH diagnostics and setting a new standard for patient care. About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care. For more information on CorVista Health, please visit: www.corvista.com Media Contact:media@corvista.com
CorVista Health Presents New Data on Non-Invasive Point of Care Testing for Pulmonary Capillary Wedge Pressure (PCWP) Elevation Using Machine Learning
New data show the machine learning algorithms may be used to detect PCWP elevation, aiding in assessment of heart failure with preserved ejection fraction (HFpEF) and pulmonary hypertension (PH) subtypesData was analyzed from patients signals collected using the CorVista System®, the world’s first non-invasive point-of-care solution currently approved for evaluating the presence of coronary artery disease and PH BETHESDA, Md., March 31, 2025 (GLOBE NEWSWIRE) — CorVista Health today announced a poster presentation showcasing preliminary results of its machine learning-based algorithm for non-invasively estimating pulmonary capillary wedge pressure (PCWP) elevation – a key indicator of heart failure with preserved ejection fraction. The poster titled ‘Point-of-Care Testing for Pulmonary Capillary Wedge Pressure Elevation Using Machine Learning on Non-invasive Signals’ was presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) in Chicago on March 30, 2025. Currently, PCWP is measured through an invasive right heart catheterization (iRHC) procedure that requires a cardiologist, pulmonologist or intensivist. The CorVista capture device collects non-invasive signals for 3.5 minutes in patients at rest, which could potentially provide an alternative to iRHC in certain patient populations. The data demonstrate how machine learning signal analysis of a symptomatic population may provide a robust, non-invasive alternative to measuring PCWP elevation, potentially making early detection of HFpEF and PH subtypes more accessible. Key findings presented in poster: The machine learning-based test achieved 0.92 ROC-AUC, 90% sensitivity, and 76% specificity when tested in 283 patients, showing strong diagnostic performance consistently across multiple subgroups defined by sex, BMI and age – both confirming and ruling out disease with a high degree of certainty.Univariate analysis identified 247 features within the collected signal features that differentiate subjects with PCWP > 18mmHg vs PCWP ≤ 18mmHg when measured via iRHC.Model has a positive likelihood ratio of 3.8 and negative likelihood ratio of 0.13, indicating that the test has a strong impact on post-test probability in both test-positive and test-negative cases.Model resulted in a diagnostic odd ratio of 29, indicating that a positive result was 29 times more likely to be observed in a patient with heart failure than a patient without. “Heart failure with preserved ejection fraction can be challenging to diagnose in part because its symptoms overlap with many other conditions and although echocardiography is an excellent modality for estimating left ventricular ejection fraction (EF), its sensitivity for diagnosing diastolic dysfunction is rather abysmal,” said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer, CorVista Health. “The new data provide preliminary results for the feasibility of our non-invasive machine learning-based test to detect elevated PCWP with a high level of accuracy. HFpEF represents over 50 percent of all cases of heart failure and has the highest morbidity and mortality. The underdiagnosis of HFpEF is arguably the largest unmet need in cardiovascular medicine today, representing approximately $25 billion in direct costs to the US healthcare system annually. Moreover, PH is also vastly underdiagnosed, and it is critically important to differentiate subtypes of pulmonary hypertension which have distinct often lifesaving guideline-directed treatments.” The exploration of a PCWP add-on to the CorVista System represents a major advancement in cardiology, with potential implications for early diagnosis, cost reduction, and broader access to cardiovascular care. The CorVista System Add-On for elevated PCWP discussed here is currently an investigational device limited by federal law (or United States) law to investigational use and is not available for commercial distribution. The system is designed to be deployed anywhere with an internet connection – addressing the unmet need in rural and underserved populations with limited access to traditional standard of care. About CorVista System® The CorVista System is a point-of -care digital health solution that detects multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze heart signals and detect issues like blocked arteries or high pressure in the lungs—all in under 30 minutes, allowing clinicians to interpret results and guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension in April 2024, with additional indications, including heart failure, in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking the first major advancement in PH diagnostics in over 40 years and setting a new standard for patient care. About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care. For more information on CorVista Health, please visit: www.corvista.com Media Contact:media@corvista.com
CorVista Health to Present New Data on Non-Invasive Point of Care Test for Pulmonary Capillary Wedge Pressure Elevation Using Machine Learning at ACC.25
BETHESDA, Md., March 20, 2025 (GLOBE NEWSWIRE) — CorVista Health today announced the upcoming poster presentation of new data on its non-invasive point of care test for pulmonary capillary wedge pressure (PCWP) elevation – a key indicator of heart failure with preserved ejection fraction (HFpEF) – using machine learning at the American College of Cardiology’s Annual Scientific Session (ACC.25), taking place March 29-31, 2025, in Chicago, IL. Details of the presentations are as follows: Title: Point-of-Care Testing for Pulmonary Capillary Wedge Pressure Elevation Using Machine Learning on Non-Invasive SignalsPresenter: Charles Bridges, M.D., Sc.D., EVP and Chief Scientific Officer of CorVista HealthFormat: PosterPresentation Number: 1166-41Date and Time: Sunday, March 30, 2025, at 12:00 p.m. ET – 1:00 p.m. ETLocation: South Hall CorVista Health will be exhibiting in the Future Hub Booth #FH8, where attendees can learn about the CorVista System. About CorVista System® The CorVista System is a point-of -care digital health solution that detects multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze heart signals and detect issues like blocked arteries or high pressure in the lungs—all in under 30 minutes, allowing clinicians to interpret results and guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension in April 2024, with additional indications, including heart failure, in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking the first major advancement in PH diagnostics in over 40 years and setting a new standard for patient care. About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care. For more information on CorVista Health, please visit: www.corvista.com Media Contact:media@corvista.com
CorVista Health Announces Leadership Succession, Appointing Adrian Lam as President and CEO
Adrian Lam appointed President and CEO of CorVista HealthDon Crawford to retire following a distinguished 42-year career in MedTechTim Attebery to serve as Chairman of the Board of Directors BETHESDA, Md., Feb. 12, 2025 (GLOBE NEWSWIRE) — CorVista Health today announced that Don Crawford will retire from his role as President and Chief Executive Officer (CEO) after a successful ten-year tenure. The Board of Directors has appointed Adrian Lam to the role of President and Chief Executive Officer. Tim Attebery, CEO of Cardiovascular Associates of America, former CEO of the American College of Cardiology (ACC) and current Board Director, will become Board Chairman. “It has been a privilege working with an exceptionally talented and dedicated team, united by a shared passion for improving cardiovascular care,” Don Crawford said. “Adrian is a dynamic, resourceful, and decisive leader who is perfectly suited to advance CorVista’s mission. He brings a proven track record of developing innovative products, building high-performing teams, and translating advanced technology into impactful medical products that improve patient outcomes.” “I am incredibly honored to lead such an innovative and mission-driven organization. The team is at the forefront of AI-enabled cardiovascular diagnostics and it’s amazing to see real patient impact even from its early days of launch. The system is able to achieve, in the doctor’s office, levels of diagnostic accuracy normally reserved for radiology. This opens up CorVista to rural and remote populations, where there is trouble with access to radiology or specialist cardiology care,” said Adrian Lam. Under Crawford’s leadership, CorVista Health has launched two pivotal U.S. Food and Drug Administration (FDA) cleared products, including the first major advancement in Pulmonary Hypertension (PH) diagnostics in more than 40 years, which secured an FDA Breakthrough Designation. He will remain on as Special Advisor to the CEO to ensure a smooth leadership transition. “As Don transitions out of his role, we want to thank him for his many years of dedicated service. We are proud of the foundation he built and look forward to partnering with Adrian to deliver on our promise to transform cardiovascular care,” said Tim Attebery. “Adrian’s diverse background as an investor-operator and a seasoned business executive uniquely positions him to navigate the future of our business and deliver meaningful value to our patients, providers, and stakeholders.” Adrian brings over 20 years of expertise in global MedTech, BioTech, and Life Science Tools. At Stryker, he led the Advanced Biomaterials R&D Group, spearheading development of multiple FDA-cleared products. As an early executive at Genesis Medtech, he helped scale the company from startup to unicorn in just over a year, driving innovation, business development, and operational integration. Previously, he managed an equity portfolio at the healthcare fund Sectoral Asset Management, building a global network of investors and industry leaders. He is also the founder of Bioworld Ventures, an investment and company-building platform run by healthcare executives and entrepreneurs. Adrian holds degrees in Biomedical Engineering and Economics from Duke University. About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care. For more information on CorVista Health, please visit: www.corvistahealth.com Contacts CorVista Health Media RelationsEmail: media@corvistahealth.com
CorVista Health and ATSS Sign Memorandum of Understanding to Bring Point-of-Care Cardiovascular Diagnostic Platform CorVista® System to the Kingdom of Saudi Arabia
BETHESDA, Md., Nov. 12, 2024 (GLOBE NEWSWIRE) — CorVista Health, Inc., a leading digital health company dedicated to improving cardiovascular disease diagnosis, today announced the signing of a Memorandum of Understanding (MOU) with Advanced Telecommunications Solutions and Services (ATSS) to explore the potential of introducing the CorVista® System into the Kingdom of Saudi Arabia. The CorVista System is the world’s first point-of-care system for evaluating the presence of significant coronary artery disease (CAD) and pulmonary hypertension (PH) in a single visit.
Analytics for Life and CorVista Health Announce the Publication of their Cost Economic Analysis for Non-Invasive Coronary Artery Disease Testing in the Journal of Visualized Experiments
TORONTO & BETHESDA, Md.–(BUSINESS WIRE)–Today, Analytics for Life, a leading innovator in advanced point-of-care diagnostics, and CorVista Health, pioneers in non-invasive cardiac diagnostics, announced a publication of a new comprehensive cost economic analysis of their non-invasive point-of-care test for Coronary Artery Disease (CAD) in the Journal of Visualized Experiments (JoVE). “We […]
CorVista Health to Present New Data on the Use of Machine Learning as a Non-Invasive Point-of-Care Rule-out Test for Heart Failure at ACC 2024
New data support the feasibility of machine learned algorithms to detect elevated left ventricular end-diastolic pressure (LVEDP) Data collected using the CorVista System®, the world’s first non-invasive point-of-care solution approved for evaluating the presence of coronary artery disease and pulmonary hypertension April 07, 2024 09:00 AM Eastern Daylight Time BETHESDA, […]
CorVista Health Announces Anjali Tiku Owens, M.D. Appointment to Medical Advisory Board
BETHESDA, Md.–(BUSINESS WIRE)–CorVista Health, Inc., a leading digital health company dedicated to improving cardiovascular disease diagnosis announces expansion of their Medical Advisory Board with the appointment of Dr. Anjali Tiku Owens. “Dr. Tiku Owens’ wealth of experience and expertise in cardiology, particularly in genetic cardiomyopathy and novel therapies, will be […]
CorVista Health Named MedTech Outlook Editor’s Choice for MedTech Startup for 2023
WASHINGTON–(BUSINESS WIRE)–CorVista Health, Inc, a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce that it has been honored with the Editor’s Choice designation as the Top MedTech Startup for 2023 by MedTech Outlook. “We are glad to feature CorVista Health as the Editor’s Choice […]