Toku’s CLAiR Platform Wins FDA Breakthrough Status

Toku Inc., a New Zealand-based company specializing in imaging tech and artificial intelligence (AI), has been granted U.S. Food and Drug Administration (FDA) breakthrough device status for its CLAiR tech.
 
Upon FDA approval the CLAiR platform, according to the company, will be the first medical device in the U.S. that can offer affordable, point-of-care, non-invasive evaluation for cardiovascular disease (CVD) risk using fundus retinal images through a routine eye exam.
 
CLAiR is designed to integrate readily with existing retinal imaging cameras for real-time CVD risk assessments, with accuracy comparable to traditional cardiovascular risk assessment tools that usually include multiple measurements and blood tests and can take weeks. The AI-powered technology interprets the many tiny signals conveyed through retinal images of blood vessels to spot elevated cardiovascular risk that may be caused by genetics or the risk factors of hypertension or high cholesterol.
 
The results can then be shared with a primary care physician, who can begin a comprehensive cardiovascular evaluation. Retinal imaging is routinely performed in a variety of eyecare settings and is increasingly being done in primary care clinics and pharmacies across the U.S.
 
“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, told the press. “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.”