Anumana Secures FDA Clearance for First-of-Its-Kind ECG-AI Algorithm for Early Detection of Pulmonary Hypertension

Anumana has received U.S. Food and Drug Administration 510(k) clearance for its pulmonary hypertension algorithm. The AI-enabled software as a medical device detects early signs of the condition from standard 12-lead electrocardiograms. It is the first pulmonary hypertension algorithm cleared for this use and previously received FDA Breakthrough Device Designation. The algorithm integrates with electronic health record systems, including ECG management platforms. It runs entirely within health system environments without transferring patient data. This allows use across care settings through existing clinical workflows. Pulmonary hypertension is a progressive, life-threatening pulmonary vascular disease estimated to affect up to 1 percent of the global population. It is often difficult to diagnose due to nonspecific early symptoms such as dyspnea. Diagnostic delays frequently exceed two years and are associated with increased morbidity and mortality. The algorithm enhances the standard 12-lead ECG by detecting subtle abnormalities that may not be visible to the human eye. It helps clinicians identify when follow-up testing such as echocardiography is warranted. Paul Friedman, chair of the Department of Cardiovascular Medicine at Mayo Clinic and a member of the Anumana advisory board, said the clearance provides clinicians with a practical solution to identify pulmonary hypertension earlier and determine appropriate next steps in care. Simos Kedikoglou, president and chief operating officer of Anumana, said the clearance is the result of rigorous clinical development and marks a meaningful step toward expanding access to AI-enabled insights at the point of care. The algorithm was developed using more than 250,000 de-identified patient records from Mayo Clinic. In an independent multi-center study of 21,066 patients across five U.S. health systems, it detected pulmonary hypertension with 73 percent sensitivity and 74.4 percent specificity in adult patients presenting with dyspnea. Separate analysis showed it identified more than 85 percent of patients with pulmonary arterial hypertension and 78 percent with chronic thromboembolic pulmonary hypertension. Mayo Clinic co-founded Anumana and has a financial interest in the company. Anumana was co-founded by nference and Mayo Clinic.