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Toku Inc. Secures FDA Breakthrough Designation for Technology that Identifies Chronic Kidney Disease Risk Through the Eye
SAN DIEGO--(BUSINESS WIRE)--Toku, Inc., a commercial medical device company specializing in imaging technology and AI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its MyKidneyAI technology. MyKidneyAI uses AI to analyze retinal images collected at routine eye exams to detect elevated chronic kidney disease (CKD) risk in people with diabetes. Most people with diabetes are not routinely screened for CKD today, resulting in the di