Anumana Receives First and Only FDA Clearance for ECG-AI Cardiac Amyloidosis Algorithm Using a Standard 12-Lead ECG

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Anumana, Inc., a leader in cardiovascular AI, today announced U.S. Food and Drug Administration (FDA) clearance of its ECG-AI™ algorithm for cardiac amyloidosis (CA) – the first and only cleared for this indication using standard 12-lead electrocardiograms (ECGs). The AI-enabled software-as-a-medical-device (SaMD), previously granted FDA Breakthrough Device Designation and selected among the first 15 devices in FDA’s Total Product Life Cycle Advisory Program pilot, is designed to help clinicians identify patients who may be at risk for CA at the point of care.