Clinical neurotechnology for objective cognition

Objective cognitive measurement for concussion care and beyond.

RetinaTek is building session-bounded, task-evoked measurement that aligns eye movement, pupil, manual-response, symptom, and stimulus-timing signals into a clearer view of neurocognitive performance.

The wedge

Concussion workflows still need better objective signal.

Many current workflows lean on symptoms, short cognitive screens, and single-modality tools. RetinaTek's approach focuses on how a person performs during controlled cognitive tasks, creating a path toward objective adjunctive support for assessment, recovery tracking, and research endpoints.

Data sophistication

Structured reports from controlled BEAM sessions.

RetinaTek does more than collect signals. Controlled sessions can be transformed into auditable outputs that connect stimulus events, gaze behavior, saccadic and manual response timing, pupil windows, validity indicators, and plain-English review summaries.

Reviewable output

Trial-level timing alignment

Each session can preserve stimulus events, cue type, block context, saccadic timing, manual response timing, and validity indicators in a reviewable structure.

Reviewable output

Multimodal quality context

Reports can pair gaze-derived measures with pupil windows, blink/data-quality signals, and structured behavioral codes instead of flattening the session into a single score.

Reviewable output

Auditable export trail

Parser version, schema version, source integrity fields, and generated timestamps support diligence, repeatability, and controlled review workflows.

Evidence snapshot

Built from a scientific foundation, presented with conservative claims.

Public copy separates evidence-backed findings, planned regulatory milestones, and future platform concepts.

74.7%

Evidence-backed, scientific review

BEAM multimodal classifier

Reported in a chronic mTBI vs control cohort, with Nagelkerke R2 = 38%.

p=.011

Evidence-backed, scientific review

Longitudinal recovery tracking

VR+ cohort N=103 showed BEAM Saccadic Inhibition Errors changed more steeply in subacute mTBI than controls.

0/151

Evidence-backed, scientific review

VR tolerability signal

0/48 in a mobile-VR pilot and 0/103 in repeated VR+ exposures across the available source materials.

AUC 0.99

Evidence-backed, scientific review

Best-effort vs fake-bad responding

BEAM saccadic-validity index reported AUC 0.99 with 95% CI 0.96-1.00.

Scalable product architecture

One evidence base, multiple launch paths.

The site is structured around reusable product, evidence, milestone, and news modules so RetinaTek can add launches without rebuilding the marketing system.

Regulated clinical path

RETINA Clinical

A VR headset-based multimodal SaMD pathway for clinician-supervised concussion evaluation, with adult, longitudinal, and adolescent regulatory milestones planned.

Validation and collaboration track

RETINA Research

A research-facing pathway for evidence generation, usability work, data-quality validation, and future substrate-aligned biomarker studies.

Future platform concept

Cognitive Readiness

A future-facing concept for opt-in, task-based cognitive readiness, personal baselines, and educational interpretation. Consumer brand remains to be decided.

Regulatory roadmap

Planned milestones are labeled as targets, not clearances.

R61

Months 1-12

Device lock, FDA pre-submission, IRB, and healthy-volunteer pilots

Planned program milestone

R33

Months 13-48

Pivotal clinical enrollment, algorithm optimization, and regulatory evidence package

Planned program milestone

Adult 510(k)

Month 45 target

Initial adult filing target for aid in the assessment of concussion

Regulatory target, not clearance

Special 510(k)

Month 51 target

Longitudinal monitoring supplement target for aid in the management of concussion

Regulatory target, not clearance

Adolescent supplement

Month 54 target

Supplement target for ages 10-17 after adolescent validation

Regulatory target, not clearance

Important review note

RETINA is presented here as an in-development technology pathway. Website copy should receive scientific, regulatory, legal, and founder review before external launch.