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 eyecare 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 eyecare," 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 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 eyecare 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.

“The eyes offer a window into overall health, and at National Vision we know an eye exam can be a critical touch point for patients to get the care they need for chronic conditions,” said Priti Patel, OD, National Vision’s senior vice president of health care strategy and development. “Toku’s groundbreaking utilization of retinal images and advancements in the AI space underscores our dedication to leveraging innovation for improved patient outcomes as well as the transformative potential of AI across medical disciplines.”

"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," added Glenn Chertow MD, MPH, professor of medicine (nephrology) and (by courtesy) professor of epidemiology and population health, and health policy at Stanford University School of Medicine.

Toku secured its first FDA breakthrough designation for its cardiovascular risk identification product, CLAiR, six months ago. FDA's breakthrough designation expedites the review process, shortening the time until technology reaches patients if cleared by the FDA.

"Given the potential impact of this technology for people with CKD, we are extremely proud to have advanced MyKidneyAI so quickly,” said Vaghefi.