The US Food and Drug Administration (FDA) has awarded Breakthrough Device status to Toku Inc’s CLAiR, an artificial intelligence (AI) platform that harnesses the diagnostic power of routine eye exams to unveil cardiovascular risks non-invasively.

The CLAiR platform, if cleared by the FDA, will be able to provide affordable, point-of-care and non-invasive evaluation for the risk of cardiovascular disease using fundus retinal images through eye exams. 

The retina, located in the back of the eye, is the only transparent part of the vascular system and can be photographed easily and non-invasively. The CLAiR technology is designed to integrate readily with existing retinal imaging cameras to provide real-time cardiovascular disease risk assessments with accuracy comparable to traditional cardiovascular risk assessment tools (which typically include multiple measurements and blood tests and can take weeks). 

The AI-powered CLAiR technology can interpret the many tiny signals conveyed through retinal images of blood vessels to identify elevated cardiovascular risk that may be caused by genetics or risk factors such as hypertension or high cholesterol. These results can then be shared with the patient’s primary care physician, who can initiate a comprehensive cardiovascular evaluation. 

Retinal imaging is routinely performed in a variety of eyecare settings and is increasingly being implemented in primary care clinics and pharmacies across the US. Once cleared by the FDA, the CLAiR technology will provide healthcare professionals across multiple settings with the ability to check for elevated cardiovascular risk before the onset of clinical disease.

“The Breakthrough Device designation that the FDA has granted to our CLAiR technology platform is a validation of the tremendous potential our CLAiR AI technology can provide to the tens of millions of patients who may unknowingly be at risk of a devastating cardiovascular condition,” says associate professor Ehsan Vaghefi, CEO and co-founder of Toku, in a release. 

Michael V. McConnell, MD, MSEE, clinical professor of preventive cardiology at Stanford University, adds in the release, “I am excited by the potential of Toku’s CLAiR technology as it can help improve health equity both in the United States and elsewhere in the world. As a clinician, I see broadening access to quality care and prevention as a critical issue, and the CLAiR retina scan technology may help improve the cardiovascular health of more people worldwide.”

Toku recently joined the Innovator’s Network, part of the American Heart Association’s Center for Health and Technology & Innovation, which will enable Toku to collaborate easily with other companies creating the next generation of high-tech healthcare solutions as the company works to bring the CLAiR platform to scale commercially, pending clearance from the FDA.

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