FDA Clears Anumana’s ECG-AI Algorithm for Cardiac Amyloidosis

Cardiovascular artificial intelligence (AI) company Anumana has received U.S. Food and Drug Administration (FDA) clearance for its ECG-AI algorithm for cardiac amyloidosis (CA).

According to the company, ECG-AI is the first and only device cleared for this indication using standard 12-lead electrocardiograms (ECGs). The AI-enabled software-as-a-medical-device (SaMD) was previously granted FDA breakthrough status and was chosen among the first 15 devices in the agency’s Total Product Life Cycle Advisory Program pilot.

Designed to help identify patients at risk for CA at the point of care, the algorithm aims to capture the subtle combinations of features indicating CA that human interpretation often misses.