The FDA has granted C. Light Technologies, Inc. 501(k) clearance for its flagship product: Retitrack, designed to track oculomotor function.
Give me some background on the company.
C. Light Technologies is a neurotech and artificial intelligence (AI) company focusing on creating advanced digital tools to detect, monitor, and develop therapeutic technology for brain and eye health.
Now talk about the Retitrack.
The Retitrack is a monocular, tabletop eye movement monitor designed to record short, non-invasive retinal video scans using advanced analytics and eye-tracking technology to assess fixation and saccadic responses at a micron level.
How exactly does it work?
The device first records high-resolution, 10-second retinal videos at a photoreceptor level, with eye motion quantification down to 0.1 degrees.
The software then removes and analyzes saccadic and fixation (microsaccades and drift) eye movements in real time, and then presents a comprehensive summary report to users that objectively quantifies the responses.
What makes this unique?
According to Christy Sheehy-Bensinger, PhD, C. Light co-founder and CEO, fixational eye movements have previously avoided clinical quantification and, as a result, pose a challenge for eye care professionals looking 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,” she stated.
Significance?
The Retitrack is now the first retinal eye-movement device cleared by the FDA for use within healthcare, giving new insights into patients’ oculomotor function.