An FDA inspection claims that eye-tracking biomarker developer RightEye misbranded and adulterated its medical device.
The agency wrote in a letter, dated Dec. 20, 2022, that it inspected RightEye’s Bethesda, Maryland facility over 10 days in June and July 2022. In this inspection, it declared the RightEye Vision System a Class II Nystagmograph medical device.
RightEye’s system records, views and analyzes eye movements in support of diagnosing visual tracking impairments. This classification came because this product is intended for use in the diagnosis of disease or other conditions. It can also offer use in the cure, mitigation, treatment or prevention of disease, or affect the structure or function of the body.
The company’s last announcement of a regulatory nod came in December 2019. RightEye said it received FDA breakthrough device designation for eye tracking to help uncover Parkinson’s disease. The system originally receive…