Bunkerhill Secures FDA Clearance for ECG-EF, Using AI to Detect Reduced Ejection Fraction from Routine ECGs

SAN FRANCISCO, Sept. 23, 2025 /PRNewswire/ -- 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 well the heart pumps by measuring the proportion of blood expelled from the left ventricle with each contraction. Low values can signal heart failure or other serious cardiovascular conditions. Millions of patients live with undiagnosed low EF until their disease is advanced, in part because echocardiography — the standard method for measuring EF — requires specialized equipment that may not always be available. By enabling EF detection from routine ECGs, one of the most common and accessible tests in medicine, ECG-EF allows clinicians to flag high-risk patients earlier and at scale.

Developed by cardiac diagnostics company Carelog, ECG-EF is now available within Bunkerhill's Carebricks platform, which enables health systems to create AI-powered workflows that both analyze patient data and automate next steps — from notifying care teams and routing referrals to streamlining prior authorization, automating registry submissions, and 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. "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, enables health systems to automate end-to-end workflows across specialties — from surfacing risks to streamlining operations — improving outcomes without adding to clinician workload. Learn more at bunkerhillhealth.com.

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SOURCE Bunkerhill Health