Auckland’s Toku Inc announced the US Food and Drug Administration has granted Breakthrough Device designation to its CLAiR platform, an investigational, AI-powered technology to assess cardiovascular disease (CVD) risk from retina scans.

CLAiR is designed to integrate seamlessly into existing retinal cameras to allow access to CVD assessments through eyecare clinics, primary care and pharmacies. If cleared for marketing, CLAiR will allow patients who may lack access to robust healthcare to benefit from earlier access to non-invasive and point-of-care CVD risk assessments, which in turn can lead to improved outcomes, said the company.

Toku’s BioAge platform is already available in Australia and New Zealand. It uses AI to estimate a person’s biological age by analysing vascular, metabolic, inflammatory and lifestyle indicators via a retinal scan.