Home » FDA Clears Eyenuk’s Diabetic Retinopathy Screening System
FDA Clears Eyenuk’s Diabetic Retinopathy Screening System
The FDA has granted Eyenuk 510(k) clearance for its EyeArt screening system for diabetic retinopathy, a complication of diabetes that can lead to blindness.
The artificial intelligence-based system can detect the condition during patients’ regular eye exams and can generate a report in less than a minute after the images are sent to a cloud system for analysis.
The company said its screening technology has been successfully tested on more than 500,000 patients.
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