Toku Obtains CE and UKCA Marks for AI Cardiovascular Risk Assessments Through the Eye
Toku announced that it has obtained CE Mark in Europe and UKCA in the United Kingdom for its patented CLAiR technology, which provides a 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 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), according to Toku. The AI-powered CLAiR technology is designed to identify 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,” Toku CEO Associate Professor Ehsan Vaghefi said in a company news release. “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.”
“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," said 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. "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.”