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Medical Devices / Submissions and Approvals

FDA Grants Breakthrough Designation to AI-based Diabetic Retinopathy Detection System

Feb. 9, 2018
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The FDA granted a Breakthrough Device designation to the artificial intelligence-based IDx-DR system from AI diagnostics company IDx.

The system’s proposed use indication would allow clinicians to automatically detect diabetic retinopathy — known to cause blindness — during office visits.

The investigational IDx-DR uses a clinically-aligned algorithm to analyze images of a patient’s retina and provide follow-up-care instructions.

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