California-based Toku has seen its artificial intelligence (AI) system for identifying  kidney disease awarded the US Food and Drug Administration (FDA) breakthrough device designation.

The MyKidneyAI system is designed to analyse images of retinal scans collected through routine eye exams and used to detect signs of chronic kidney disease (CKD) risk in people living with diabetes in a bid to catch the condition before it can develop.

The 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 key contributor to CKD. As a result of the breakthrough designation, Toku is now working with US-based eye-care companies including National Vision to distribute its devices across the country.

Research by the National Kidney Foundation estimates that approximately 15% of the US population is currently living with some form of kidney disease, at the same time nine out of 10 people with CKD are unaware that they have the condition. CKD is generally asymptomatic until it reaches an advanced stage, requiring dialysis or kidney transplantation.

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

“We have now achieved two FDA Breakthrough designations in under a year, which is particularly impressive because we are one of only a handful of startup companies to do so in the FDA Breakthrough Devices program’s history. This is a testament to our team’s innovative approach and commitment to making a significant impact in healthcare.”

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Previously Toku received breakthrough designation for its CLAIiR platform, which similarly uses AI and imaging technology to scan for signs of cardiovascular disease. The US charity, the National Kidney Foundation estimates that the Medicare program spends more than $130bn, more than 24% of total spending, on patients with kidney disease, end-stage CKD accounts for an additional 7%.

Priti Patel, senior vice president of National Vision, added: “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.”

The FDA has already greenlit several technologies aimed at using digital imaging of a patient’s eyes and AI to look for signs of conditions such as diabetes. Previously, LumineticsCore received FDA clearance for its own device for identifying diabetic retinopathy by examining retinal images.