Cognivue vs Neurotrack (2026)
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.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. Cognivue and Neurotrack are each graded against the same capability taxonomy, from each vendor's own public materials and the regulatory record, under the AI Health Index verification standard. No vendor pays for placement, and no vendor has reviewed this page. How this evidence is graded
Plain facts
| Fact | Cognivue | Neurotrack |
|---|---|---|
| Primary category | Clinical Decision Support | Clinical Decision Support |
| Founded | Not recorded | 2012 |
| Headquarters | Rochester, New York, United States | Redwood City, California, United States |
| Website | cognivue.com | neurotrack.com |
Side by Side
Each record in one paragraph
Written to be quoted whole. Each paragraph states what the AI Health Index verified about the vendor, with the caveats attached. Generated from this pair’s live capability grades, so it moves when a grade moves.
The AI Health Index awards Cognivue its top capability grade on several axes, including Autonomy and Oversight Model, Clinical and Operational Evidence and FDA and Regulatory Status. Set against Neurotrack, Cognivue grades higher on several axes, including AI Centrality, Autonomy and Oversight Model and Model Supply Chain Disclosure. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
The AI Health Index awards Neurotrack its top capability grade on EHR and Interoperability Depth, Deployment Model and Data Residency and Setting and Specialty Coverage. Set against Cognivue, Neurotrack grades higher on several axes, including HIPAA and BAA Posture, EHR and Interoperability Depth and Deployment Model and Data Residency. Its thinnest published disclosure sits on Model Supply Chain Disclosure. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
Questions buyers ask
Should we choose Cognivue or Neurotrack?
On the axes where the AI Health Index separates them, Cognivue grades higher on several axes, including AI Centrality, Autonomy and Oversight Model and Model Supply Chain Disclosure, and Neurotrack grades higher on several axes, including HIPAA and BAA Posture, EHR and Interoperability Depth and Deployment Model and Data Residency. Cognivue leads on the greater share of scored axes, but the split means the decision turns on which constraint is binding rather than on an overall winner.
Where do Cognivue and Neurotrack differ most?
The widest separation the AI Health Index records between Cognivue and Neurotrack is on Model Supply Chain Disclosure, where Cognivue grades B and Neurotrack grades D. That axis sits in the AI Capability group, so it should carry the most weight for a buyer whose binding constraint is how much of the work the model itself is trusted to do.
Where do Cognivue and Neurotrack grade the same?
The AI Health Index grades Cognivue and Neurotrack the same on several axes, including Model and Technology Transparency, AI Safety and PHI Stewardship and Security Certifications and Trust Center. Neither holds an advantage the index can evidence on those axes, so they should not carry weight in a selection between these two.
What have Cognivue and Neurotrack not disclosed?
At the last review, at least one of Cognivue and Neurotrack published thin or absent detail on Model Supply Chain Disclosure. The AI Health Index treats an absent disclosure as a gap in the public record rather than a failure of the product, so these are the axes to get in writing during diligence instead of inferring from the grade.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers. The full set for this category is on the Clinical Decision Support page.
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.