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

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Anumana received FDA 510(k) clearance on March 28, 2026 for its pulmonary hypertension (PH) algorithm, the first AI-enabled PH detection algorithm cleared for use with standard 12-lead ECGs1

The algorithm was previously designated as an FDA Breakthrough Device1

In an independent multi-center study of 21,066 patients across five U.S. health systems, the algorithm detected PH with 73% sensitivity and 74.4% specificity in patients presenting with dyspnea1

In a separate real-world analysis, the algorithm identified more than 85% of patients with pulmonary arterial hypertension (PAH) and 78% with chronic thromboembolic pulmonary hypertension (CTEPH)1

The algorithm was developed using over 250,000 de-identified patient records from Mayo Clinic1

The software integrates with EHR systems and existing clinical workflows without transferring patient data outside the health system environment1

Pulmonary hypertension affects up to 1% of the global population and is often difficult to diagnose, with diagnostic delays frequently exceeding two years1

Sources:

1. https://anumana.ai/anumana-secures-fda-clearance-for-first-of-its-kind-ecg-ai-algorithm-for-early-detection-of-pulmonary-hypertension/