Toku, a health technology company founded by Ehsan Vaghefi, has developed an AI-powered retina scan and diagnostic platform named CLAiR that predicts cardiovascular risks and related diseases by examining a patient’s eyes. Vaghefi’s personal experience of growing up with a blind father due to congenital glaucoma inspired his mission to bring affordable and accessible disease screening to a wider population through technology.

Toku’s CLAiR platform utilizes AI to analyze retinal images and calculate heart disease risk, hypertension, or high cholesterol within 20 seconds. The company recently secured “breakthrough device status” from the U.S. Food and Drug Administration (FDA), accelerating the accreditation process for CLAiR.

The platform’s innovative approach reads signals from blood vessels in retinal images, offering a non-invasive and quick method for detecting cardiovascular risks. Toku aims to integrate CLAiR into routine eye exams, making it a part of standard practice at optometry retail stores, primary care offices, ophthalmology clinics, and pharmacies equipped with retinal cameras.

The FDA breakthrough designation not only expedites the accreditation process but also positions Toku to receive automatic reimbursement code approval upon final FDA approval.

Toku, headquartered in San Diego, California, raised $8 million in a Series A funding round from National Vision and Topcon Healthcare. The company, still in its early stages, plans to initiate a pivotal trial in mid-2024 and aims for market deployment by the end of 2025.

Once cleared by the FDA, Toku claims it will be the first medical device company in the U.S. to offer an affordable, non-invasive method for detecting cardiovascular disease through retinal imaging. Toku emphasizes compliance with privacy regulations, including the Health Insurance Portability and Accountability Act (HIPAA) and ISO 13483, ensuring data security and access restrictions.

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