FDA Grants Breakthrough Device Status to Toku’s Patented Cardiovascular Risk AI (CLAiR) Platform
Toku, Inc., a commercial medical device company specializing in imaging technology and AI, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its patented CLAiR technology.
- Toku, Inc., a commercial medical device company specializing in imaging technology and AI, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its patented CLAiR technology.
- The CLAiR platform, if cleared by the FDA, will be the first medical device in the US market that can provide affordable, point-of-care and non-invasive evaluation for risk of cardiovascular disease (CVD) using fundus retinal images through a routine eye exam.
- Working with its partners, Toku is aiming to establish the largest network for CVD risk assessment across the US and then globally.
- View the full release here: https://www.businesswire.com/news/home/20231102799522/en/
Toku's AI-powered CLAiR technology uses retina scans during regular eye exams to detect cardiovascular risk non-invasively.