RightEye Eye-Tracking System Receives FDA 510(k) Clearance
BETHESDA, Md.—RightEye has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RightEye system for recording, viewing, and analyzing eye movements to identify visual tracking impairment in patients. “We are thrilled to receive clearance from the FDA,” said Adam Gross, co-founder and CEO of RightEye, based here. “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,” Gross said. 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 the FDA classifies as a nystagmograph, includes EyeQ tests, reports and training tools, has a number of applications, such as functional vision screening, reading assessments, sports vision assessment, and training and brain health.