Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Pulmonary Hypertension Early

Shots:

• The FDA has granted 510(k) clearance to an AI-enabled PH algorithm, a software-as-a-medical-device designed to detect early signs of PH, cleared for use with standard 12-lead ECGs
• The PH algorithm detects subtle early PH patterns in standard 12-lead ECGs & integrates with EHR & ECG management systems, plus it operates entirely within the health system environment without transferring patient data
• The algorithm was developed using >250,000 Mayo Clinic patient records & showed 73% sensitivity & 74.4% specificity in a 21,066-patient multi-center study across US, while in a real-world analysis, it identified >85% of PAH & 78% of CTEPH cases using ECGs between symptom onset & diagnosis

Ref: Businesswire   |   Image: Anumana  |   Press Release

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