RightEye Eye-Tracking System Receives FDA 510(k) Clearance
Published: Oct 09, 2018
The RightEye System Uses Advanced Eye-Tracking Technology to Quickly, Easily, and Accurately Expose Vision and Brain Health Issues
BETHESDA, Md., Oct. 9, 2018 /PRNewswire/ -- RightEye LLC, an award-winning health technology company that uses eye tracking to revolutionize patient care and improve vision performance, today announced that the company's vision system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The FDA has cleared the RightEye™ system for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in patients.
Using advanced eye-tracking technology and analytics, the RightEye system is the first portable, all-in-one solution for vision-derived health screening, tracking eye movements and correlating them to health issues. The system, which includes RightEye EyeQ™ tests, reports and training tools, has various applications, including:
"We are thrilled to receive clearance from the FDA," said Adam Gross, RightEye co-founder and CEO. "It is the culmination of years of scientific research, product development and hard work that have led us to this critical milestone. RightEye is committed to providing innovative, proven eye-tracking solutions that empower doctors to differentiate and expand their practices while transforming the lives of their patients through improved health and wellness. 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."
"The RightEye system has been an asset to my practice for its ability to help identify conditions that may have otherwise gone unnoticed," said Adam Clarin, OD, practicing optometrist at Clarin Eye Care in Miami, Florida. "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."
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