Cognivue vs Neurotrack
Regulatory substance against distribution reach, and the regulatory gap is the one buyers most often miss. Cognivue holds a De Novo, an actual FDA clearance that created this device category, plus the strongest bias study in the field and independent evidence of superior test retest reliability. Neurotrack is FDA registered rather than cleared, which sounds similar but means the agency was notified of the device rather than reviewing a submission, and this is precisely the terminology ambiguity Cognivue's documented De Novo resolves. What Neurotrack offers instead is deployment: cloud based on any device where Cognivue needs dedicated hardware, integration with all major EHRs where Cognivue generates a one page report at the device, the broadest distribution in the category, and the only published SOC 2 of the four. If your failure mode is regulatory defensibility and demographic validity, start with Cognivue, and accept the hardware. If your failure mode is screening a whole population inside existing EHR workflows, start with Neurotrack, understanding registration is not clearance.
- The regulatory distinction that decides it: Cognivue holds the De Novo classification DEN130033, an actual FDA clearance that created the device category, graded A, where Neurotrack is FDA registered rather than cleared, a materially weaker status, graded C; the similar sounding language conceals a real difference buyers must catch.
- A bias study designed as one: the FOCUS study enrolled 452 participants across six US sites stratified by age, education, sex, race, and ethnicity, graded A on governance from empirical validation, where Neurotrack designs for inclusivity with culturally agnostic symbols but publishes no subgroup data, graded B.
- More computation and independent evidence: adaptive psychophysics across more than 130,000 data points, graded B on AI centrality where Neurotrack grades C, validated as equally effective as the MoCA with superior test retest reliability.
- Population scale deployment is the design: cloud based on any device with no specialised hardware, graded A on deployment where Cognivue's dedicated hardware grades C, sized to fit inside a Medicare Annual Wellness Visit.
- The interoperability gap is the widest in the category: Neurotrack integrates with all major EHRs feeding Annual Wellness Visit and RADV workflows, graded A, where Cognivue generates a one page report at the device and grades C.
- The only published security attestation of the four: SOC 2 and HIPAA stated directly, graded B, where Cognivue has none located, and the broadest distribution with named health system customers, graded A on setting.
Side-by-Side
| Axis | C Cognivue |
N Neurotrack |
|---|---|---|
| AI Centrality | ||
| Autonomy and Oversight Model | ||
| Model and Technology Transparency | ||
| Clinical and Operational Evidence | ||
| AI Safety and PHI Stewardship | ||
| HIPAA and BAA Posture | ||
| Security Certifications and Trust Center | ||
| FDA and Regulatory Status | ||
| AI Governance and Bias Disclosure | ||
| EHR and Interoperability Depth | ||
| Deployment Model and Data Residency | ||
| Commercial Transparency | ||
| Setting and Specialty Coverage |
The load bearing fact is regulatory and this index states it plainly: Cognivue's De Novo is a reviewed clearance that established the category, while Neurotrack's FDA registration means it has notified the FDA of its device rather than had a submission reviewed, and no 510(k) or De Novo was located for it. Cognivue uses the accurate distinction, Neurotrack uses the accurate word registered, but they are not equivalent positions. Cognivue also leads on the empirical bias study and on independent evidence. Neurotrack's advantages are entirely on deployment and distribution: cloud based on any device against Cognivue's capital intensive hardware, the best interoperability in the category against Cognivue's worst, and the only SOC 2 disclosure of the four. Neurotrack's evidence grades B partly because much of its publication record predates the current product. Neither publishes pricing.