Anumana Receives Novel FDA Clearance for AI-Based ECG Tool to Detect Pulmonary Hypertension

Anumana has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its artificial intelligence algorithm designed to detect early signs of pulmonary hypertension (PH) using standard 12-lead electrocardiograms (ECGs).

The software, previously granted Breakthrough Device Designation, is the first cleared AI tool for PH detection using routine ECG data. 

It is intended to help clinicians identify subtle cardiac patterns that may indicate early disease, enabling earlier follow-up testing and diagnosis within existing clinical workflows.

Pulmonary hypertension is a progressive and serious condition affecting the lungs and right side of the heart. It is often difficult to diagnose in its early stages because symptoms are non-specific, leading to delays in treatment. 

The AI system aims to address this gap by improving the diagnostic value of standard ECG tests that are already widely used in healthcare settings.

The algorithm integrates directly into hospital systems and electronic health records without transferring patient data outside the clinical environment, supporting secure and real-time decision-making.

Clinical studies involving tens of thousands of patients have shown that the system can detect pulmonary hypertension with moderate-to-high sensitivity and specificity, including in cases of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

The approval represents a step forward in the use of AI-based tools to enhance early cardiovascular disease detection and improve patient outcomes through faster clinical intervention.