Clinically relevant populations
Validation should include appropriate injured and comparison groups.
Clinical Development
A staged path toward regulated clinical use.
RETINA is currently an in-development neurocognitive measurement platform. RetinaTek is pursuing staged validation and regulatory strategy for future clinician-supervised applications, beginning with concussion and recovery workflows.
Current status
Regulatory status
RETINA is not currently FDA-cleared to diagnose, treat, cure, mitigate, or prevent any disease or medical condition. RetinaTek's current work focuses on research use, pilot deployments, validation, usability, data-quality workflows, and preparation for future regulatory submissions.
Initial clinical-development focus: concussion and recovery.
RetinaTek's planned clinical-development pathway begins with clinician-supervised assessment workflows for concussion and recovery monitoring. The goal is to generate objective adjunctive neurocognitive metrics that can complement, not replace, clinician judgment and established standards of care.
Validation principles
Repeatable measurement
Longitudinal designs should evaluate change over recovery windows.
Data quality and validity
Eye tracking enables review of attention, engagement, blinks, and task compliance.
Regulatory alignment
Claims, endpoints, and intended use should be shaped through regulatory feedback.
Development roadmap
Stage 1
Research and device lock
Finalize hardware/software configuration, data-quality workflows, and intended-use assumptions.
Stage 2
FDA pre-submission engagement
Align proposed claims, endpoints, comparator strategy, and validation study design.
Stage 3
Clinical validation
Enroll target populations and comparison groups to evaluate performance against pre-specified endpoints.
Stage 4
Initial regulatory submission
Prepare evidence package for future FDA review, subject to validation outcomes and FDA feedback.
Stage 5
Expansion
Potential future extensions may include longitudinal monitoring, adolescent populations, and additional neurocognitive indications.