Anumana has received US Food and Drug Administration (FDA) 510(k) clearance for an AI-powered algorithm that detects early signs of pulmonary hypertension using standard 12-lead echocardiograms (ECGs) — making it the first pulmonary hypertension algorithm cleared for this widely available diagnostic tool. Previously granted US Food and Drug Administration “Breakthrough Device Designation”, the algorithm integrates directly into existing clinical workflows and Electronic Health Records (EHR) systems without transferring patient data.
Developed using over 250,000 de-identified patient records from Mayo Clinic, the algorithm demonstrated 73% sensitivity and 74.4% specificity in an independent multi-centre study of over 21,000 patients. In a real-world analysis, it identified more than 85% of pulmonary arterial hypertension (PAH) patients and 78% of chronic thromboembolic pulmonary hypertension (CTEPH) patients from echocardiograms taken between symptom onset and diagnosis — suggesting meaningful potential for earlier detection of these two treatable pulmonary hypertension subgroups.
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