SAN DIEGO — Toku, Inc., a commercial medical device company specializing in imaging technology and artificial intelligence (AI), has announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to its MyKidneyAI technology, which 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.
“This designation accelerates the FDA approval process for MyKidneyAI, paving the way for a market release by Q1 2026. As a vital tool for individuals with diabetes, MyKidneyAI will become an integral part of diabetic screening in optometry and comprehensive eye care,” Ehsan Vaghefi, Toku’s president and CEO, told VMAIL. “Combined with our cardiovascular risk assessment AI, CLAiR, which received FDA breakthrough device designation in November 2023, Toku’s innovative platform will offer comprehensive systemic disease screening through the eye. Our goal is to make a visit to your local eye care provider, a comprehensive health check, revolutionizing health care with Toku’s platform.”
Toku is working closely with its strategic investors, Topcon Healthcare, a provider of medical devices and software solutions for the global eye care community, and optical retailer National Vision to provide MyKidneyAI in the U.S. market. As reported in VMAIL, National Vision and Topcon initially invested $8 million in Series A funding for Toku Inc.’s AI retinal imaging technology.
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