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Toku’s CLAiR Platform Receives Breakthrough Device Status from the FDA

Toku’s CLAiR Platform Receives Breakthrough Device Status from the FDA

November 03, 2023

Toku announced that its patented CLAiR technology has received Breakthrough Device designation from the FDA. Toku plans to introduce the CLAiR platform as the first non-invasive medical device in the US market, offering cost-effective point-of-care assessment for cardiovascular disease (CVD) risk using fundus retinal images during routine eye exams, pending FDA clearance.

The company, in collaboration with partners, aims to establish the largest network for CVD risk assessment in the US and globally. Toku has also joined the American Heart Association's Innovator's Network, facilitating collaboration with innovative healthcare companies as they work to scale the CLAiR platform commercially.

The retina is the sole transparent segment of the vascular system, allowing for easy and non-invasive photography. CLAiR technology is specifically designed to seamlessly integrate with existing retinal imaging cameras, enabling real-time cardiovascular disease (CVD) risk assessments that rival the accuracy of traditional methods. These traditional methods involve multiple measurements and blood tests, often taking weeks. AI-driven CLAiR can analyze subtle signals within retinal images of blood vessels to detect heightened cardiovascular risk attributable to genetics or risk factors like hypertension and high cholesterol.

The results can then be shared with the patient's primary care physician, initiating a comprehensive cardiovascular evaluation. Retinal imaging is a standard practice in various eye care settings and is increasingly adopted in primary care clinics and pharmacies across the US. Once FDA-approved, CLAiR technology will empower healthcare professionals in diverse settings to assess elevated cardiovascular risk proactively, even before clinical symptoms manifest.

“Toku’s mission is to make identifying disease accessible for everyone, everywhere, all the time. 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,” Associate Professor Ehsan Vaghefi, CEO and Co-Founder of Toku, said in a company news release. “This designation greatly de-risks our clinical development and regulatory pathway for the technology, as the FDA’s Breakthrough Devices program offers medical device companies accelerated review processes, enhanced guidance, and prioritized evaluation, facilitating quicker market access for innovative technologies and encouraging the development of devices that significantly improve patient care.”

“Predictive analytics technology, provided it has been proven to be accurate and applicable to the population using it, has tremendous potential to benefit patients by identifying those at highest risk so treatments and preventive measures can be initiated quickly. The medical literature has published many examples using different types of eye imaging to predict risk of other systemic conditions beyond cardiovascular disease, such as neurologic or kidney disease. Therefore, further developing this type of technology is very exciting as cardiovascular disease remains a significant cause of morbidity and mortality in the whole country,” said April Maa, MD, Professor of Ophthalmology, Emory University School of Medicine.