Anumana, a leader in cardiovascular AI, 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.
Cardiac amyloidosis is a serious, life-threatening condition caused by abnormal protein deposits in the heart that can lead to heart failure if not recognized early. It is frequently underdiagnosed due to nonspecific symptoms that overlap with common cardiac conditions. Early diagnosis is critical, and timely intervention can meaningfully improve outcomes for patients. While a standard ECG is routinely obtained during the evaluation of these symptoms, human interpretation often misses the subtle combinations of features that may indicate CA. With FDA clearance, Anumana’s AI-driven software-as-a-medical-device (SaMD) is now available for clinical use, enabling analysis of ECG data to help identify patients who may benefit from further evaluation.