Toku, of San Diego, California, announced Feb. 5 that it had obtained CE and UK Conformity Assessment (UKCA) marking for its patented CLAiR technology—AI-powered software that identifies elevated cardiovascular risk through a standard retinal image by analyzing tiny changes in the retina and its vasculature.
CLAiR is designed to integrate with existing retinal cameras to provide real-time cardiovascular risk assessments with accuracy comparable to standard methods, which typically require blood testing.
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. Toku said CLAiR results can be shared with a patient’s primary care physician, who can then initiate a comprehensive cardiovascular evaluation.
Toku has an active partnership with Topcon, and Toku’s software can been used in conjunction with Topcon’s retinal cameras—the NW400/500 and Maestro 2 devices. Toku is seeking de novo classification through the US FDA, which has granted the software its breakthrough device designation.