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Toku Inc. Secures FDA Breakthrough Designation for Technology that Identifies Chronic Kidney Disease Risk Through the Eye

MyKidneyAI Becomes the Company’s Second Innovation to Recently Receive this FDA Distinction

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 disease not being detected until it has developed to an advanced stage where straightforward interventions are no longer effective.

“MyKidneyAI’s groundbreaking early screening technology offers a way to detect CKD in its earliest stages, when therapies can be instituted to attenuate or prevent disease progression and may significantly reduce the roughly 360 patients starting dialysis every day in the United States,” said Glenn Chertow M.D., M.P.H, Professor of Medicine (Nephrology) and (by courtesy) Professor of Epidemiology and Population Health, and Health Policy at Stanford University School of Medicine.

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