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RightEye Eye-Tracking System Receives FDA 510(k) Clearance




(PRESS RELEASE) BETHESDA, MD — RightEye LLC, a company that uses eye tracking to revolutionize patient care and improve vision performance, 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-inone 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 a number of applications, including:

  • Functional Vision Screening—RightEye functional vision test helps to quickly and objectively identify a host of functional vision issues that affect quality of life and automatically recommends computer-based exercises for patients to do at home.
  • Reading Assessments—RightEye Reading EyeQ tracks reading proficiency in real time, identifying hidden vision issues associated with learning difficulties.
  • Sports Vision Assessment & Training—RightEye Sports Vision EyeQ identifies opportunities to strengthen performance-related aspects of vision, while Sports Vision Trainer offers personalized exercises to athletes looking to improve coordination and reaction times.
  • Brain Health—RightEye Brain Health EyeQ showcases the severity levels of vision skill problems and how this may relate to brain performance. It also provides computer-based vision exercises to help address oculomotor issues.

“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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