Shots:
- The US FDA has granted clearance to ECG-AI algorithm, a software-as-a-medical-device designed for cardiac amyloidosis (CA), cleared for use with standard 12-lead ECGs
- ECG-AI algorithm analyzes ECG waveforms to detect CA-related patterns not visible to clinicians, integrating into existing workflows using routine ECGs without additional testing to help identify at-risk pts & guide next steps
- Initially developed at Mayo Clinic, ECG-AI showed 78.9% sensitivity & 91.2% specificity in a 25,525-patient multi-center study across the US in adults with signs, symptoms, or comorbidities of CA
Ref: Businesswire | Image: Anumana |Press Release
Related News: Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Pulmonary Hypertension Early
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