Toku gains CE and UKCA marks for retinal image analysis technology

The company’s AI-powered technology uses retinal images captured in routine eye exams to evaluate risk of cardiovascular disease

A graphic indicating the inside of the retina with text reading: cholesterol, blood pressure, smoking, cardiovascular, diabetes

A company specialising in artificial intelligence (AI) assessments of retinal images, Toku, has obtained CE and UKCA marks for its patented CLAiR technology.

The AI–powered technology uses retinal images captured during a routine eye exam to evaluate the risk of cardiovascular disease (CVD), identifying minute changes in the retina and vasculature.

The CLAiR technology is designed to integrate with existing retinal cameras to provide accurate, affordable, and non-invasive CV risk assessments. Toku suggests that the real-time risk assessments have an accuracy comparable to gold standard assessments which typically require blood tests and can take weeks.

The commercial medical device company said the CE and UKCA Mark approval is a milestone that will support access to markets in Europe and the UK.

Professor Ehsan Vaghefi, Toku CEO, said: “I believe that a retinal image can be considered the ‘fifth vital’ along with temperature, heart rate, respiration rate, and blood pressure.”

“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.”

Toku suggested that, with retinal imaging routinely performed in primary eye care, the CLAiR technology would enable healthcare professionals to identify elevated cardiovascular risk in adult patients with no known history of CVD.

Professor John Marshall, emeritus professor of ophthalmology at University College London and Kings College London, holds the original patents for refractive surgery.

Marshall commented: “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.”

Early identification of risk allows for the timely modification of lifestyles and for early treatments to be enacted, Marshall said.

“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,” he continued.

Last year, Toku gained the support of Topcon, becoming the manufacturer’s first Entrepreneur in Residence.