Toku Inc. Secures FDA Breakthrough Designation for Technology that Identifies Chronic Kidney Disease Risk Through the Eye
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.
- 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.
- Toku developed MyKidneyAI to help identify individuals with diabetes who have elevated CKD risk via a simple eye exam available in eye care or primary care settings.
- FDA's Breakthrough designation expedites the review process, shortening the time until technology reaches patients if cleared by the FDA.