Anumana has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its pulmonary hypertension algorithm, an Artificial Intelligence-enabled software-as-a-medical-device that detects early signs of pulmonary hypertension, a serious and progressive condition affecting the lungs and right side of the heart. The algorithm previously received FDA Breakthrough Device Designation and is cleared for use with standard 12-lead electrocardiograms (ECGs), broadening access across care settings. It is designed to enhance routine ECGs by identifying subtle abnormalities that may not be visible to the human eye and to support decisions on follow-up testing such as echocardiography within existing clinical workflows.
Pulmonary hypertension is estimated to affect up to 1% of the global population. Early symptoms can be non-specific, such as dyspnea, and delays in diagnosis frequently exceed two years. Those delays are linked to increased morbidity and mortality, underscoring the value of earlier detection. The software integrates with EHR systems, including ECG management platforms, and runs entirely within the health system environment without transferring patient data. Anumana says the clearance strengthens the clinical utility of standard 12-lead ECGs by bringing real-time decision support to the point of care.
Anumana’s ECG-Artificial Intelligence pulmonary hypertension algorithm was developed using over 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, ECG-Artificial Intelligence detected pulmonary hypertension with 73% sensitivity and 74.4% specificity in adult patients presenting with dyspnea. In a separate real-world analysis study of patients with an ECG available between symptom onset and pulmonary hypertension diagnosis, ECG-Artificial Intelligence identified more than 85% of patients with pulmonary arterial hypertension (PAH) and 78% with chronic thromboembolic pulmonary hypertension (CTEPH). Those findings suggest a potential opportunity to support earlier detection of two treatable pulmonary hypertension subgroups.
The clearance adds to Anumana’s portfolio of workflow-integrated cardiovascular Artificial Intelligence products. The company, co-founded by nference and Mayo Clinic, develops software-as-a-medical-device tools for early detection, clinical decision-making, and intraoperative guidance. Its FDA-cleared ECG-Artificial Intelligence LEF and ECG-Artificial Intelligence pulmonary hypertension algorithms are available in the U.S. and eligible for reimbursement. Mayo Clinic co-founded Anumana and has a financial interest in the company.
