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.
IDx-DR is an AI-based retinal diagnostic software designed to automatically detect more than mild diabetic retinopathy in adults with diabetes using retinal fundus images acquired with a specific fundus camera. It helps clinicians by providing screening results that indicate the presence or absence of disease, enabling timely referral and treatment to prevent vision loss.
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