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 EW10-EC02 Endoscopy Support Program is an AI-driven software tool designed to support endoscopists by detecting colon polyps and adenomas in real time during standard colonoscopy exams. It processes real-time endoscopic video images from White Light Imaging and Linked Color Imaging to highlight potential lesions, helping clinicians improve diagnosis and patient outcomes without replacing clinical judgment.

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