New Zealand-based medical device company Toku has secured the CE and UKCA marks for its patented CLAiR technology to evaluate cardiovascular disease (CVD) risk.

The CLAiR technology provides rapid, accurate, non-invasive CVD risk assessments using standard retinal images captured during a routine eye exam.

The retina, which lies in the back of the eye, is the only part of the vascular system that can be photographed easily and non-invasively.

The AI-powered technology identifies elevated levels of cardiovascular risk by analysing the smallest changes in the retina and its vasculature.

Toku CEO Ehsan Vaghefi said: “I believe that 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. 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 CLAiR technology enables the assessment at the point of care, making the detection of CVD risk more accessible, especially for underserved populations who lack healthcare access.

It enables widespread access to CVD assessments through eye care clinics, primary care, and pharmacies, said the company.

Also, the AI-powered technology easily integrates with existing retinal cameras to provide CVD risk assessments in real-time, with accuracy comparable to gold-standard methods.

CLAiR provides results that can be shared with a patient’s primary care physician, who can initiate a complete cardiovascular evaluation to guide prevention.

In April last year, Toku secured $8m in a Series A Preferred financing round, co-led by US-based optical retailer National Vision and medical solutions provider Topcon Healthcare.

In November last year, the medical device company received the US Food and Drug Administration (FDA) breakthrough device designation for its AI-powered CLAIiR platform.