FDA Grants Clearance to C. Light's Retinal Eye Movement Monitor

FDA Grants Clearance to C. Light's Retinal Eye Movement Monitor

May 18, 2023

C. Light Technologies announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking device, the Retitrack. This innovative technology aims to revolutionize our understanding of oculomotor function by utilizing the retina, offering medical professionals concrete and objective metrics.

The Retitrack is a monocular, tabletop eye movement monitor specifically designed to record, visualize, measure, and analyze the temporal characteristics of fixation and saccadic responses when exposed to visual stimuli. Its primary purpose is to assist healthcare practitioners operating within healthcare settings such as physician's offices, clinics, and laboratories.

The Retitrack captures 10-second, high-resolution retinal videos at the photoreceptor level, enabling precise measurement of eye motion down to an impressive 0.1 degrees. The accompanying software works in real-time to extract and analyze both fixation, including microsaccades and drift, as well as saccadic eye movements. Furthermore, it generates a comprehensive summary report, providing clinical professionals with invaluable insights for interpretation and assessment.

"Fixational eye movements have previously eluded clinical quantification, posing a significant challenge to health care professionals who are aiming to improve prognostic care. With our novel technology, we've unlocked the potential of one of the smallest motor movements in the human body, offering invaluable data that will drive the future of clinical care," Christy Sheehy-Bensinger, PhD, CEO and co-founder of C. Light, said in a company news release.

"We are gratified that our device is cleared for marketing and that we hit our seed funding milestone. Our device and its accompanying software will revolutionize healthcare by empowering clinicians with significant new insights into an individual's oculomotor function, as opposed to existing devices reporting on retinal structure alone.,” she added.