SAN DIEGO–(BUSINESS WIRE)–Toku, Inc., a commercial medical device company specializing in AI assessment of retinal images, announced today that it has obtained CE and UKCA Marks for its patented CLAiR technology. This significant milestone underscores Toku’s commitment to maintaining the highest standards of quality and safety and allows access to […]
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FDA Grants Breakthrough Device Status to Toku’s Patented Cardiovascular Risk AI (CLAiR) Platform
AUCKLAND, New Zealand–(BUSINESS WIRE)–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 image
Toku joins Innovators’ Network at American Heart Association Center for Health Technology & Innovation
SAN DIEGO–(BUSINESS WIRE)–Toku Inc, a provider of an AI-based screening tool for detection of cardiovascular risk through retinal imaging, has joined the American Heart Association Center for Health Technology & Innovation’s (the Center) Innovators’ Network. The Center is focused on building and fostering health technology relationships to develop innovative and scalable solutions. The Innovators’ Network is a health care technology consortium that connects entrepreneurs, providers, resea