Bunkerhill Secures FDA Clearance for ECG-EF, Using AI to Detect Reduced Ejection Fraction from Routine ECGs
SAN FRANCISCO, CA — September 23, 2025 — Bunkerhill Health today announced it has received U.S. Food and Drug Administration (FDA) clearance for ECG-EF, an artificial intelligence algorithm that detects reduced left ventricular ejection fraction (LVEF), a key indicator of heart failure, using data from routine 12-lead electrocardiograms (ECGs). The clearance highlights Bunkerhill’s expansion into ECG as a new input modality, complementing its FDA-cleared imaging algorithms.
Ejection fraction reflects how effectively the heart pumps by measuring the proportion of blood expelled from the left ventricle with each contraction. When this measure is low, it can indicate heart failure or other serious cardiovascular conditions. Millions of patients worldwide live with reduced EF that remains undiagnosed until symptoms are severe, in part because echocardiography — the standard test for EF — requires specialized equipment and expertise that may not be readily available. By enabling EF detection from routine 12-lead ECGs, one of the most common and accessible tests in medicine, ECG-EF makes it possible to flag high-risk patients earlier and at a much greater scale.
Developed by Carelog, a cardiac diagnostics company focused on advancing the electrocardiogram as a tool for earlier identification of heart disease, ECG-EF is now available within Bunkerhill’s Carebricks platform. Carebricks allows health systems to create tailored, AI-powered workflows that not only analyze patient data and surface insights, but also take action by automating next steps — from notifying care teams and routing referrals to streamlining prior authorization, automating registry submissions, and even triggering actions in third-party platforms.
“FDA clearance of ECG-EF underscores our ability to bring best-in-class AI into real clinical practice,” said Nishith Khandwala, Co-founder and CEO of Bunkerhill Health. “Heart failure is a leading cause of hospitalization worldwide, and earlier identification of patients with reduced ejection fraction can profoundly impact outcomes. By embedding this capability into Carebricks, we’re giving health systems the tools to flag patients sooner and support clinicians in ensuring they receive the right care.”
“With the ECG-EF algorithm to diagnose a weak heart muscle, we now have a tool that brings powerful cardiac diagnostics into everyday clinical settings — noninvasive, rapid, and accessible,” said Dr. Jag Singh, Professor and Cardiologist at Mass General Hospital, Harvard Medical School, and Advisor on Carelog’s Board of Directors. “By detecting impaired heart pumping function early, even before symptoms arise, this algorithm offers the chance to intervene sooner, improve outcomes, and save lives.”
About Bunkerhill Health
Bunkerhill Health delivers generative AI for clinical reasoning and action. Its flagship platform, Carebricks, analyzes structured and unstructured patient data to understand each patient’s full history, apply AI-powered reasoning across all available context, and automate any appropriate next steps. Supporting workflows that range from surfacing risks to identifying treatment candidates, optimizing care pathways, and streamlining operations, Carebricks helps health systems improve outcomes, increase efficiency, and close care gaps without adding to clinician workload.
About Carelog
Carelog is a cardiac diagnostics company with a mission to transform the electrocardiogram into a tool for earlier identification of heart failure, structural heart disease, and related cardiac conditions — often before symptoms arise. Its proprietary HridAI™ platform uses artificial intelligence to uncover new clinical insights from the world’s most widely used heart test, validated in diverse patient populations. By enabling physicians to intervene sooner, improve outcomes, and save lives, Carelog is redefining how cardiac disease is detected and managed.