AI Technology to Detect CKD in Retinal Images Gets Boost From FDA

California-based medical device company Toku received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its MyKidneyAI technology.

MyKidneyAI uses artificial intelligence (AI) to analyze retinal images collected at routine eye exams to detect increased chronic kidney disease (CKD) risk in people with diabetes. Most patients with diabetes are not routinely screened for CKD, so the disease often goes undetected until it has advanced and simple interventions are no longer effective.

The AI system works by taking photos of the retina, the only part of the cardiovascular system that can be photographed, to look for signs of microvascular disease, a primary contributor to CKD. With the breakthrough designation, Toku is now able to work with eye care companies to distribute its devices across the United States.

“Given the potential impact of this technology for people with CKD, we are extremely proud to have advanced MyKidneyAI so quickly,” said Ehsan Vaghefi, chief executive officer of Toku.