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Toku Eyes, a New Zealand-based healthcare AI company, is launching its tool that assesses heart risk through a retinal scan in the U.S.

The tool, called CLAiR, uses an AI platform to identify cardiovascular threats more accurately than existing risk calculators, the company claims. The platform recognizes subtle changes in aspects like blood vessels and pigmentation to identify a person’s risk of a stroke or heart attack in the next five years.

Many Americans with diabetes are at risk of long-term complications like heart disease and blindness. Early diagnosis is critical for mitigating morbidity, but diagnosis has historically been a challenge.

“If you can see the future, you can change it,” Ehsan Vaghefi, co-founder and CEO of Toku Eyes, said in an announcement. “By looking inside the eyes, we get an in-depth view of what is happening inside the entire body to better assess the risk factors of each individual and identify high-risk individuals before their condition worsens. Our goal is to make health screening simple and easy to access for the entire population so we can get in front of underlying health risks and improve patient outcomes.”

Since using a retinal camera and the AI software requires minimal training, it is more cost-effective and accessible, the company argues. The AI platform uses an image of the back of the eye to do its assessment. It then provides personalized health guidance or recommends a specialist referral. The company says the technology also works accurately with low-resolution images.

Toku Eyes is also aiming to launch a separate tool to detect blinding conditions in the U.S. by the end of this year, pending FDA approval. As part of its expansion to the U.S., the company is partnering with EyeCheq, a company Toku Eyes says is building out a network of self-service retinal image kiosks across the U.S. Another partner is Unified-Imaging, a cloud-based solution for capturing image data.

The company’s platform is currently used as part of diabetic screening services in the private and public sectors in New Zealand, according to its press release.

CLAiR is being released as a wellness device and therefore does not require FDA clearance, the company told Fierce Healthcare. This classification will also enable Toku Eyes to share cardiovascular risk data with payers to help improve the overall health of their members. Altogether, Toku Eyes hopes to be at more than 1,500 locations across the U.S. by 2025.


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By Anastassia Gliadkovskaya