Concussion programs
Dedicated programs that already manage repeat follow-up and recovery workflows.
RT-TRACE · In development
Objective cognitive measurement across concussion recovery
RT-TRACE is being developed as a short, repeatable assessment of cognitive performance under load for concussion-recovery research and future specialty clinical workflows.
The product synchronizes eye movements and manual reaction time with controlled cognitive tasks, then converts performance patterns into interpretable outputs. Before clearance, RetinaTek is pursuing paid research and sponsor-funded observational pilots that run alongside usual care.
RT-TRACE remains investigational and is not currently FDA-cleared, FDA-approved, or authorized to diagnose concussion or direct recovery decisions.
Built for concussion specialty workflows
Concussion recovery programs already manage serial follow-up, persistent symptoms, return-to-activity questions, and multidisciplinary care. Objective cognitive performance remains difficult to measure consistently across visits.
RT-TRACE is designed to translate RETINA's task-evoked measurement architecture into a brief, supervised assessment that trained staff can administer within existing research and future cleared clinical workflows.
Hospital outpatient care
Clinical programs with repeat visits, multidisciplinary care, and service-line leadership.
Sports medicine
Programs supporting adult and pediatric patients across recovery and return-to-activity workflows.
Neurorehabilitation
Recovery-focused settings that need practical longitudinal measurement and workflow evidence.
Neurology and PM&R
Specialty practices managing persistent symptoms, cognitive function, and coordinated follow-up.
Occupational medicine
Programs where sponsors and care teams need evidence about workflow, utilization, and repeat assessment.
Objective cognitive performance under controlled load
RT-TRACE uses RetinaTek's task-evoked measurement architecture to capture cognitive performance during a brief, standardized assessment. The goal is to provide practical, repeatable outputs that help research teams and, after appropriate clearance, clinicians and patients understand performance patterns over time.
Speed
How efficiently the participant responds to task-relevant information.
Cognitive control
How consistently the participant manages attention, inhibition, and competing demands.
Consistency
How stable performance remains across repeated task events.
Task performance
How accurately the participant completes controlled cognitive challenges.
Change over time
How performance trends across repeat assessments.
Designed for real clinic deployment
RT-TRACE is designed to fit supervised specialty and research workflows without requiring a full neuropsychological testing environment.
Brief assessment
Designed for short, low-burden administration.
Staff-administered
Can be run by trained clinical staff in supervised workflows.
Headset-based
Creates a controlled visual environment for task-evoked measurement.
Interpretable outputs
Supports practical reporting for research teams, clinicians, and participants.
Repeatable
Designed for baselining and longitudinal follow-up.
Repeat-follow-up fit
Designed for programs that already see patients across multiple recovery visits.
One assessment shows performance. A series can show change.
Concussion recovery is longitudinal. RT-TRACE is being developed so the same controlled cognitive challenge can be repeated across visits, creating a consistent performance trend for research and future cleared clinical workflows.
Sponsored pilots build the evidence and operating model
Paid or sponsor-funded observational pilots can build workflow, utilization, data-quality, economic, and reference proof while advancing product and evidence readiness for future clinical markets.
Paid traction
Sponsor-funded research and observational pilots can demonstrate that real customers will fund the work.
Workflow learning
Reveals what works in administration, training, reporting, support, and repeat testing.
Repeat-testing experience
Builds operational experience with longitudinal cognitive performance measurement.
Product refinement
Improves report design, user experience, data flow, and service delivery.
Customer credibility
Strengthens conversations with clinics, researchers, strategic partners, and investors.
Bridge to future pathways
Helps de-risk future regulated clinical-development work.
Clear product and regulatory boundary
Concussion recovery is RetinaTek's commercial market focus. The planned first 510(k) is RT-Focus, a computerized cognitive assessment aid. A later condition-specific clearance is required before RT-TRACE can carry concussion-specific clinical claims.
Currently framed as
- Investigational cognitive-performance measurement under load
- Paid research and sponsor-funded observational pilots
- Repeat measurement across follow-up visits
- Workflow, utilization, and data-quality evidence
- Future specialty concussion-care application after clearance
Not claimed
- Diagnosis of concussion, TBI, or any other condition
- A current FDA-cleared recovery-monitoring claim
- A basis for treatment, benefits, or return-to-activity decisions before clearance
- Replacement for clinician judgment, imaging, biomarkers, or specialist evaluation
Regulatory and claims status
RetinaTek has completed FDA Q-Submission engagement, and that feedback informs its active 510(k) strategy. The planned first 510(k) is RT-Focus, a computerized cognitive assessment aid. RT-TRACE remains investigational, and concussion-specific claims require appropriate validation and regulatory clearance.
Help build the evidence for objective concussion-recovery measurement.
RetinaTek is developing sponsored observational pilots with concussion programs, research teams, and organizations that can support governed evidence generation and real-world workflow learning.