First-Of-Its-Kind AI Tool Detects Pulmonary Hypertension from Standard ECGs

Pulmonary hypertension is a progressive, life‑threatening disease that is frequently missed early because symptoms such as dyspnea are nonspecific and diagnostic delays can exceed two years. Earlier identification can guide timely testing and management and may mitigate morbidity and mortality. A newly FDA‑cleared algorithm now offers earlier detection of pulmonary hypertension from routine 12‑lead electrocardiograms.

Anumana’s ECG‑AI PH algorithm, an artificial intelligence–enabled software‑as‑a‑medical‑device, has received U.S. Food and Drug Administration 510(k) clearance for detecting early signs of pulmonary hypertension. It is the first pulmonary hypertension algorithm cleared for use with standard 12‑lead electrocardiograms, enabling broad use across care settings. The software had previously received Breakthrough Device Designation.

The algorithm augments the standard 12‑lead electrocardiogram by identifying subtle abnormalities that may not be visible to the human eye. It is intended to signal when follow‑up testing, such as echocardiography, may be appropriate within existing workflows. The software integrates with electronic health record systems, including electrocardiogram management platforms, and operates entirely within the health system environment without transferring patient data.

ECG‑AI PH was developed using more than 250,000 de‑identified patient records from Mayo Clinic. In an independent, multi‑center study of 21,066 adults across five U.S. health systems who presented with dyspnea, the algorithm detected pulmonary hypertension with 73% sensitivity and 74.4% specificity. In a separate real‑world analysis of patients with an electrocardiogram available between symptom onset and diagnosis, it identified more than 85% of pulmonary arterial hypertension cases and 78% of chronic thromboembolic pulmonary hypertension cases.

“Pulmonary hypertension is often difficult to recognize until it has progressed significantly, leaving patients and physicians at a disadvantage. FDA clearance of Anumana’s PH algorithm provides clinicians with a practical solution to identify PH earlier and determine appropriate next steps in care, expanding the clinical utility of routine ECGs.” said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic and a member of the Anumana advisory board.

“The FDA clearance of our Pulmonary Hypertension algorithm is the result of rigorous clinical development and regulatory work, and it marks a meaningful step toward expanding access to AI-enabled insights at the point of care,” said Simos Kedikoglou, President & COO of Anumana.

“As the first PH algorithm cleared for use with standard 12‑lead ECGs, it is broadly accessible across care settings, integrates directly into existing clinical workflows, and supports clinical decision‑making in real time, with the potential to help identify patients earlier in their disease course. This milestone reflects Anumana’s broader vision to expand the role of ECGs in identifying cardiovascular risk earlier and at scale," added Kedikoglou

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