Toku obtains CE and UKCA marks for AI cardiovascular risk assessments through the eye

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Toku’s AI technology, CLAiR, provides fast, accurate, non-invasive cardiovascular disease (CVD) risk assessments using standard retinal images

An image of the Toku CLAiR system. The AI-powered technology identifies elevated cardiovascular risk by analysing minute changes in the retina and its vasculature. Image courtesy of Toku Inc.

The AI-powered technology identifies elevated cardiovascular risk by analysing minute changes in the retina and its vasculature. Image courtesy of Toku Inc.

Toku Inc 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 markets in Europe and the United Kingdom.

According to the company’s news release, 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.1

The company noted in its news release 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 analysing 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.1

Moreover, the company noted in its news release the 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.

Ehsan Vaghefi, Toku CEO and associate professor of optometry and vision science at the University of Auckland, New Zealand, said he believes a retinal image can be considered the ‘fifth vital’ along with temperature, heart rate, respiration rate and blood pressure.

“The CE and UKCA marks allow us to bring CLAiR to patients across multiple geographies,” Vaghefi said in the news release. “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, pointed out 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,” he said in the news release. “Such early risk identification allows timely modification of lifestyle and even earlier treatment to prevent or delay onset.

Prof Marshall went on to add, "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.”

Reference
1. Toku Obtains CE and UKCA Marks for AI Cardiovascular Risk Assessments Through the Eye. www.businesswire.com. Published February 5, 2024. Accessed February 5, 2024. https://www.businesswire.com/news/home/20240205212146/en/Toku-Obtains-CE-and-UKCA-Marks-for-AI-Cardiovascular-Risk-Assessments-Through-the-Eye
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