RightEye Secures FDA 510(k) Clearance for Eye-Tracking Platform
RightEye Secures FDA 510(k) Clearance for Eye-Tracking Platform

A couple months ago, Medgadget reviewed RightEye’s EyeQ vision tests and training tools in addition to speaking with Co-Founder and CSO Dr. Melissa Hunfalvay. As a platform to help providers assess eyesight, brain and reading disorders, and performance issues, RightEye captures much of its data using state-of-the-art eye tracking technology and realizes engagement through gamification. Yesterday, RightEye announced receipt of 510(k) clearance from the U.S. FDA for their technology to record, view, and analyze eye movement in support of identifying visual tracking impairment.


The announcement represents an important regulatory milestone for a company that has already realized broad tracking across optometrists, hospitals, rehabilitation facilities, professional sports teams, and the U.S. military. Dr. Adam Clarin, a practicing optometrist at Clarin Eye Care in Miami, Florida and one such early adopter of RightEye’s technology commented that, “The RightEye system has been an asset to my practice for its ability to help identify conditions that may have otherwise gone unnoticed. The FDA clearance adds an extra layer of confidence for my patients and my practice. The quick and easy-to-administer tests, coupled with the objective and quantifiable reports, not only guides my decision on the type of treatment to recommend but also makes it simple to explain issues to patients and parents.”

Regarding the path that brought RightEye to today, RightEye Co-Founder and CEO Adam Gross said, “It is the culmination of years of scientific research, product development and hard work that have led us to this critical milestone.” In terms of what the future holds, Adam added, “As we continue to pioneer the field of eye-tracking technology, we’ll advance the science and discover new solutions and applications that will benefit patients and doctors alike.”

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