EYE-SYNC
FDA-cleared VR-based eye tracking platform for concussion diagnosis and visual impairment assessment
Company profile
Company profile
NeuroSync is a digital health company that has developed EYE-SYNC, an FDA-cleared virtual reality-based platform for assessing brain health and neurological function through eye movement analysis. The company addresses a critical gap in neuro health diagnostics, where over 83 million Americans suffer from neurological conditions but lack access to validated, objective diagnostic tools. EYE-SYNC leverages proprietary algorithms and artificial intelligence to measure eye tracking synchronization and gaze fixation, providing clinicians with actionable data in less than 60 seconds. The technology has been validated through 15 years of clinical research conducted in collaboration with the US Department of Defense and the Brain Trauma Foundation. In 2021, the FDA cleared EYE-SYNC as an aid to concussion diagnosis, and in 2019 it received FDA Breakthrough Device Designation. The platform serves multiple markets including healthcare providers, biopharma companies conducting CNS trials, sports organizations managing athlete safety, and military organizations optimizing personnel performance. With over 5,000 certified clinicians and more than 405,000 patient assessments completed, NeuroSync's portable, wireless platform can be deployed anywhere from clinical settings to remote facilities. The technology features 0.9 test-retest reliability, HIPAA-compliant cloud storage, exportable results via PDF or API integration, and unlimited usage with no per-test fees. NeuroSync's solution represents the intersection of digital health, AI, and objective neurological data to transform patient care and performance optimization.
Company description SyncThink official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Hybrid · On Premise deployment with recorded integration context.
Recorded integration context: EMR systems via API, Secure data transfer capabilities.
Company milestones
FDA clearance as aid to concussion diagnosis (2021); FDA Breakthrough Device Designation (2019); Over 405,000 patient assessments completed; 5,188 certified clinicians
Partnerships
02 · Flagship portfolio
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FDA-cleared VR-based eye tracking platform for concussion diagnosis and visual impairment assessment
Customizable digital health platform incorporating AI and objective measures for brain health and performance
03 · Research intelligence
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Research
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Clinical validation
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Regulatory
K202927 · 510k · Oct 2, 2021
04 · Company-reported outcomes
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Less than 60 seconds per assessment
0.9 reliability score
5,188 certified clinicians
405,000+ assessments completed
1.5+ billion data points collected
Improved patient throughput and workflow efficiency
Organizations achieve ROI while advancing patient care
Better diagnosis of concussion and patient education
Great addition for patient care and community education about better concussion diagnosis
Student athlete concussion assessment and care
Viable asset and strategy in care of student athletes, serving as leader in concussion assessment
Improved diagnostic accuracy and workflow efficiency
More accurate diagnosis in shorter period of time with objective measurements
Holistic concussion management for student-athletes
Solved major part of concussion management previously lacking, enabling more holistic approach to student-athlete care
Vestibular therapy with objective patient engagement
Patients enjoy objective data and stay engaged session to session watching their numbers improve over time
Portable and clinically sensitive concussion assessment tool
Easy to administer, portable, and clinically sensitive tool that is important part of clinical practice
05 · Leadership
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06 · Company updates
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07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.
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