CAMBRIDGE, Mass. — Anumana has received U.S. Food and Drug Administration clearance for an artificial intelligence-powered algorithm designed to detect early signs of pulmonary hypertension using standard electrocardiograms, the company said.
The software, cleared through the FDA’s 510(k) pathway, is the first algorithm approved for identifying pulmonary hypertension from a standard 12-lead ECG, enabling broader use across healthcare settings. The tool had previously been granted Breakthrough Device Designation.
Pulmonary hypertension is a serious and progressive condition affecting the lungs and right side of the heart and is often difficult to diagnose early due to non-specific symptoms such as shortness of breath. Diagnostic delays can exceed two years and are associated with worse outcomes, underscoring the need for earlier detection.
Anumana’s algorithm analyzes ECG data to detect subtle abnormalities that may not be visible to clinicians, helping identify patients who may require follow-up testing such as echocardiography. The system integrates into existing electronic health record platforms and operates within hospital environments without transferring patient data externally.
“Pulmonary hypertension is often difficult to recognize until it has progressed significantly, leaving patients and physicians at a disadvantage,” said Paul Friedman, M.D., chair of the Department of Cardiovascular Medicine at Mayo Clinic and a member of Anumana’s advisory board. “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.”
The algorithm was developed using more than 250,000 de-identified patient records from Mayo Clinic. In an independent multi-center study involving more than 21,000 patients across five U.S. health systems, the technology demonstrated 73% sensitivity and 74.4% specificity in detecting pulmonary hypertension among adults presenting with shortness of breath.
In a separate real-world analysis, the system identified more than 85% of patients with pulmonary arterial hypertension and 78% of those with chronic thromboembolic pulmonary hypertension, suggesting potential to support earlier diagnosis of these treatable subtypes.
“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 and chief operating officer 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.”
Anumana said the clearance expands its portfolio of AI-driven cardiovascular tools and reflects its broader effort to use ECG data to identify disease risk earlier and at scale. The company was co-founded by Mayo Clinic, which retains a financial interest in the business.
