egnite, Pathway Labs and Stamford Health Launch First-of-Its-Kind Pilot Using ECG-Based AI to Help Clinicians Identify and Manage Structural Heart Patients

egnite's CardioCare^® Platform is deploying Pathway Labs' recently cleared ECG algorithm at Stamford Health to more effectively prioritize and coordinate care for echo-ready patients.

ALISO VIEJO, Calif., Oct. 29, 2026 /PRNewswire/ -- egnite, Inc., a technology company advancing guideline-directed cardiovascular care and real-world evidence, today announced a clinical pilot with Pathway Labs and Stamford Health (Stamford, Connecticut) to deploy Pathway's novel electrocardiogram (ECG) screening results within egnite's CardioCare^® platform.

EchoNext, developed by Pathway Labs and recently cleared by the U.S. Food and Drug Administration, will analyze 12-lead ECG waveforms at Stamford Health for signals associated with a range of cardiac conditions — including signs of structural heart disease, heart failure, and pulmonary hypertension. It is the first AI tool cleared in the U.S. to screen for this breadth of structural heart conditions from a single ECG.

Detection alone does not change care. ECG-based screening can identify large numbers of patients who could warrant follow-up, but an AI flag is only one signal in a patient's record. The CardioCare platform, in use across more than 80 heart programs, helps close that gap. After EchoNext flags a study, the CardioCare platform evaluates the finding alongside the patient's longitudinal record — prior diagnoses, labs, and history — to surface a focused, pre-qualified group of patients likely to benefit from echocardiographic follow-up (echo-ready patients) within the workflows care teams already use. Because CardioCare tracks each patient from initial flag through imaging, evaluation, and treatment decision, the pilot will also measure the downstream clinical impact of ECG-based screening — including echo completion rates and time to specialist evaluation. CardioCare is designed to integrate screening outputs from multiple sources into a single clinical workflow; Pathway Labs is the first algorithm partner to go live.

"AI can identify patients at risk, but that's only the first step. The real challenge is making sure those patients receive the appropriate follow-up evaluation and treatment without creating additional burden for already busy clinical teams. CardioCare is designed to bridge that gap by providing the clinical context and workflow needed to move patients efficiently from detection to diagnosis and, ultimately, appropriate treatment," said Rahul Sharma, MD, MBBS, FRACP, Director of Structural Interventions and Associate Director of the Cardiac Catheterization Laboratory at Stanford Health Care, and Senior Medical Advisor of egnite. "This pilot with Pathway Labs is exciting because it will allow us to evaluate the entire care pathway to quantify how this AI can meaningfully improve real-world patient care."

"The team at Stamford Health is excited to bring this novel technology to our patients and strengthen how we screen for heart disease. Since 2022, we've used the CardioCare platform to identify and evaluate nearly 300 patients with significant heart disease who were not otherwise on a path to treatment," said Arzhang Fallahi, MD, Director of Structural Heart, Stamford Health. "Bringing Pathway Labs' AI-enabled ECG screening into our program extends that approach to the tens of thousands of ECGs we perform each year, giving us the chance to catch heart disease even earlier."

"This new and exciting algorithm will vastly expand our current AI programs in cardiac imaging and improve quality of care for our patients," said David Hsi, MD, Chief of Cardiology and Co-Director of Heart & Vascular Institute at Stamford Health.

"This technology started as a research effort and has demonstrated strong patient impact in the FDA validation studies. Partnering with egnite lets us validate the algorithm in real-world practice across several health systems — and we're energized that Stamford Health is the first. egnite's clinical workflow infrastructure and reach across 80+ heart programs make them the ideal partner to take this from regulatory milestone to the bedside," said Pierre Elias, MD, CEO of Pathway Labs.

Edwards Lifesciences is contributing funding to the pilot as part of a collaboration with egnite and Pathway Labs to advance earlier identification of patients with structural heart disease.

About egnite, Inc.

egnite, Inc. is a technology company advancing guideline-directed cardiovascular care and real-world evidence. egnite's CardioCare^® platform is deployed at more than 80 heart programs, drawing on data from more than 1,200 cardiovascular care facilities in its network, to identify and prioritize cardiovascular patients. CardioCare combines practical AI, clinical logic aligned to ACC/AHA guidelines, and workflow integration to help hospitals move more patients into evidence-based care pathways. The egnite Registry, built on de-identified EHR data from approximately 15.7 million patients and 6 million echo reports, gives life sciences and research teams a longitudinal view of the patient journey. The company is headquartered in Aliso Viejo, California. For more information, visit www.egnitehealth.com.

The CardioCare platform is not intended for use in the diagnosis, cure, mitigation, treatment or prevention of cardiovascular diseases.

About Pathway Labs

Pathway Labs builds AI that helps clinicians catch heart disease earlier, starting with EchoNext, a screening tool that reads routine ECGs to identify patients who should go on to an echocardiogram. Started by Dr. Pierre Elias and a world-leading team of cardiac AI researchers from Columbia University Irving Medical Center and NewYork-Presbyterian, Pathway Labs is dedicated to bringing rigorously validated cardiovascular AI out of the research setting and into everyday clinical care to help patients live longer, healthier lives.

About Stamford Health

Stamford Health is a non-profit independent health care system serving Fairfield County, Connecticut. With more than 4,100 employees committed to delivering expert, compassionate, person-centered care, patients and their families receive an array of health and wellness services through the system's 305-bed Stamford Hospital; 40 Stamford Health Medical Group offices; and a growing number of ambulatory locations.

Stamford Health consistently receives top tier clinical and safety recognitions from U.S. News & World Report, Leapfrog, The American Nurses Credentialing Center, Planetree, Centers for Medicare & Medicaid Services and Castle Connolly, and is a Certified™ Great Place to Work. Stamford Health brings specialized care to the community through partnerships with leading academic medical centers including Columbia University Vagelos College of Physicians and Surgeons and Dana-Farber Brigham Cancer Center and highly regarded care providers like Hospital for Special Surgery and Oula Health.

Through the Stamford Hospital Foundation, Stamford Health receives support to sustain core medical programs, acquire the latest technology and enhance patient-care overall.

For more information, visit StamfordHealth.org. Like us on Facebook and follow us on Instagram, LinkedIn, and YouTube.

About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

Discover more at www.edwards.com.

SOURCE egnite Health