Anumana Secures FDA Clearance for First-of-Its-Kind ECG-AI Algorithm for Early Detection of Pulmonary Hypertension
CAMBRIDGE, Mass. – March 28, 2026 – Anumana, a leader in cardiovascular AI, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its pulmonary hypertension (PH) algorithm, an AI-enabled software-as-a-medical-device (SaMD) that detects early signs of PH, a serious and progressive condition affecting the lungs and right side of the heart. The algorithm, which previously received FDA Breakthrough Device Designation, is the first PH algorithm cleared for use with standard 12-lead electrocardiograms (ECGs), making it broadly accessible across care settings.
PH is a progressive, life-threatening pulmonary vascular disease estimated to affect up to 1% of the global population.1 It is often difficult to diagnose2 due to non-specific early symptoms, such as dyspnea, with delays frequently exceeding two years.3 These delays are associated with increased morbidity and mortality, highlighting the need for earlier detection.4 Anumana’s algorithm enhances the standard 12-lead ECG by detecting subtle abnormalities that may not be visible to the human eye, helping clinicians identify when follow-up testing, such as echocardiography, is warranted using existing clinical workflows.
