FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

The Low Ejection Fraction AI-ECG Algorithm by Anumana, Inc. is a software tool that analyzes 12-lead ECG signals using AI to aid in screening for patients with low left ventricular ejection fraction (≤ 40%). It helps clinicians identify adults at risk of heart failure to decide if further cardiac evaluation is needed. It works quickly on routine ECGs and does not replace diagnostic imaging but supports clinical judgment.

FDA #
K232699
Product Code
QYE
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