C. Light Technologies has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its retinal eye device Retitrack. According to the Massachusetts, US-based healthtech startup is the first retinal eye-movement monitor to be cleared for use in healthcare for non-invasive clinical assessments .
The device is a tabletop eye movement monitor that records 10-second, high-resolution, and non-invasive retinal video scans at the photoreceptor level. Using accompanying software, it analyses temporal characteristics of fixational and saccadic eye motion down to 0.1 degrees. Fixation movements such as microsaccades and drift can be extracted by the software to generate a real-time report for healthcare practitioners.
It is intended for use by healthcare practitioners and will facilitate further clinical insights into a patient’s oculomotor function. Current technology only reports on retinal structure, according to C.Light CEO and co-founder Dr Christy Sheehy-Bensinger.
Oculomotor function is an important clinical test. Abnormalities of eye movements may indicate vision impairment and are sometimes symptoms for other conditions. Research has previously been conducted in using technology to diagnose autism spectrum disorder (ASD) in children based on visual gaze.
“Fixational eye movements have previously eluded clinical quantification, posing a significant challenge to healthcare 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,” said Dr Sheehy-Bensinger.
C. Light has raised more than $8m with funding from Yamaha Motor Ventures and Creative Ventures. The company has also been awarded grants from the National Institute of Health and the Alzheimer’s Drug Discovery Foundation.