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Toku Obtains CE and UKCA Marks for AI Cardiovascular Risk Assessments Through the Eye

Toku, Inc., a commercial medical device company specializing in AI assessment of retinal images, announced today that it has obtained CE and UKCA Marks for its patented CLAiR technology. This significant milestone underscores Toku’s commitment to maintaining the highest standards of quality and safety and allows access to the Europe and United Kingdom markets.

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The AI-powered technology identifies elevated cardiovascular risk by analysing minute changes in the retina and its vasculature (Photo: Business Wire)

CLAiR provides accurate, affordable, non-invasive evaluation for the risk of cardiovascular disease (CVD) at the point of care using retinal images captured during a routine eye exam.

The retina, located in the back of the eye, is the only part of the vascular system that can be photographed easily and non-invasively. The CLAiR technology integrates readily with existing retinal cameras, to provide real-time CVD risk assessments with accuracy comparable to gold standard cardiovascular risk assessments (which typically require blood tests and can take weeks). The AI-powered CLAiR technology identifies elevated cardiovascular risk by analyzing minute changes in the retina and its vasculature. CLAiR results can be shared with a patient’s primary care physician, who can initiate a comprehensive cardiovascular evaluation to guide prevention.

Retinal imaging is routinely performed in many eye care settings and is increasingly being used in pharmacy and primary care clinics across the UK and EU. CLAiR will enable healthcare providers in various settings to identify elevated cardiovascular risk in adult patients with no known history of cardiovascular disease.

“I believe that a retinal image can be considered the ‘fifth vital’ along with temperature, heart rate, respiration rate, and blood pressure,” says Toku CEO Associate Professor Ehsan Vaghefi. “The CE and UKCA marks allow us to bring CLAiR to patients across multiple geographies. In my vision of the future, a retinal image analysis is an integral part of a comprehensive screening for major diseases such as cardiovascular or kidney disease.”

Professor John Marshall, the holder of the original patents for refractive surgery and Emeritus Professor of Ophthalmology at both University College London & Kings College, London says “The eye is the only organ of the body where we can non-invasively view and image blood vessels. The advent of artificial intelligence has enabled analysis of retinal images to predict the occurrence and time course of numerous diseases of the vascular system, including heart attacks and strokes. Such early risk identification allows timely modification of lifestyle and even earlier treatment to prevent or delay onset. Toku’s CLAiR algorithm is a major breakthrough in the field of cardiovascular diseases and should result in lifesaving interventions and improved quality of life for innumerable individuals throughout the world.”

About Toku, Inc.

Toku, Inc. based in San Diego CA, is a cutting-edge technology company that specializes in converting routine eye exams to comprehensive health screening by developing AI-powered tools. The company’s first commercialized product, BioAge, uses AI to analyze biometric markers in the retina to accurately identify an individual’s biological age. In the United States the CLAiR platform has received Breakthrough Device designation from the FDA. Toku is committed to making its technology widely accessible through major partnerships across the world. Toku’s Series A financing was co-led by National Vision, Inc., one of the largest optical retailers in the United States, and Topcon Healthcare, a leading provider of medical devices and intelligent software solutions for the global eye care community.

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