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