Bunkerhill Health's AI Algorithm Gains FDA Clearance for Heart Failure Detection

Bunkerhill Health has received U.S. Food and Drug Administration (FDA) clearance for its ECG-EF algorithm, which uses artificial intelligence to detect reduced left ventricular ejection fraction (LVEF) from routine 12-lead electrocardiograms (ECGs). Announced in a press release, this development marks Bunkerhill's expansion into ECG as a new input modality, complementing its existing FDA-cleared imaging algorithms.

The ECG-EF algorithm is designed to identify low ejection fraction, a key indicator of heart failure, by analyzing data from one of the most common and accessible tests in medicine. This capability allows clinicians to flag high-risk patients earlier and at scale, potentially improving patient outcomes by enabling timely intervention.

Developed by cardiac diagnostics company Carelog, ECG-EF is integrated into Bunkerhill's Carebricks platform. This platform supports health systems in creating AI-powered workflows that analyze patient data and automate subsequent actions, such as notifying care teams and routing referrals. The integration of ECG-EF into Carebricks aims to streamline clinical operations and enhance patient care without increasing clinician workload.