Cognivue vs Linus Health (2026)
The two governance leaders of the category, both with strong independent evidence, at opposite ends of the AI spectrum. Cognivue is the settled foundation: it holds the De Novo that created this regulatory category, its FOCUS study is a model bias investigation, and its scope as an adjunctive tool is drawn precisely, though it runs only on dedicated hardware with no EHR integration. Linus Health is the frontier: genuinely AI native, analysing drawing and speech behaviour to predict amyloid status, with peer reviewed method transparency and the most direct engagement with cultural bias in this sweep. The tension is regulatory certainty against capability, because Linus is cleared for cognitive assessment while its commercial claim has moved to biomarker prediction, a more consequential use much of which sits in conference abstracts. If your failure mode is a defensible, demographically validated screen on a settled clearance, start with Cognivue. If your failure mode is predicting amyloid pathology for treatment eligibility, start with Linus, and track which claims are cleared versus research.
- The regulatory foundation of the category: Cognivue holds the De Novo classification DEN130033, the first FDA cleared computerised cognitive test, graded A on regulatory status, where Linus is cleared for cognitive assessment but its headline claim has moved to amyloid prediction, a different intended use, holding it at B.
- A bias study designed and reported as one: the FOCUS study enrolled 452 participants across six US sites stratified by age, education, sex, race, and ethnicity, matching Linus at the top of the governance axis from empirical validation rather than design intent.
- Settled scope with independent evidence: validated as equally effective as the MoCA with superior test retest reliability, indicated precisely as an adjunctive tool, graded A on autonomy, with the reliability that matters for baselining and monitoring over time.
- Genuinely AI native: the DCTclock analyses the drawing process, stylus dynamics and speech acoustics with no paper equivalent, graded A on AI centrality where Cognivue's adaptive psychophysics grades B, and A on model transparency for peer reviewed method disclosure where Cognivue grades B.
- Biomarker prediction is the capability: DCTclock correlated with amyloid PET in cognitively normal people and the DCR predicting PET status in the 930 participant Bio-Hermes-001 study, addressing treatment eligibility rather than screening alone.
- Deployment without dedicated hardware: iPad administered with a remote option and EHR integrated health system workflows, graded B on both deployment and interoperability where Cognivue's dedicated hardware and one page report grade C on each.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. Cognivue and Linus Health 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 | Linus Health |
|---|---|---|
| Primary category | Clinical Decision Support | Clinical Decision Support |
| Founded | Not recorded | 2019 |
| Headquarters | Rochester, New York, United States | Boston, Massachusetts, United States |
| Website | cognivue.com | linushealth.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 Linus Health, Cognivue grades higher on Autonomy and Oversight Model, FDA and Regulatory Status and Commercial Transparency. 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 Linus Health its top capability grade on several axes, including AI Centrality, Model and Technology Transparency and Clinical and Operational Evidence. Set against Cognivue, Linus Health grades higher on several axes, including AI Centrality, Model and Technology Transparency and HIPAA and BAA Posture. 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 Linus Health?
On the axes where the AI Health Index separates them, Cognivue grades higher on Autonomy and Oversight Model, FDA and Regulatory Status and Commercial Transparency, and Linus Health grades higher on several axes, including AI Centrality, Model and Technology Transparency and HIPAA and BAA Posture. Linus Health 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 Linus Health differ most?
The widest separation the AI Health Index records between Cognivue and Linus Health is on Autonomy and Oversight Model, where Cognivue grades A and Linus Health grades B. 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 Linus Health grade the same?
The AI Health Index grades Cognivue and Linus Health the same on several axes, including Model Supply Chain Disclosure, Clinical and Operational Evidence and AI Safety and PHI Stewardship. Neither holds an advantage the index can evidence on those axes, so they should not carry weight in a selection between these two.
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.
This is the strongest pairing in the category because both grade A on clinical evidence and both grade A on governance, the only two vendors here to do so, from opposite methods: Cognivue empirically through the stratified FOCUS study, Linus by naming the cultural and educational bias failure mode directly and publishing where its instrument is sensitive to it, including a South Asian cohort. The split is regulatory settledness against AI capability.
Cognivue's De Novo is a finished, category creating clearance and its scope is precisely drawn; Linus is the more advanced model but its cleared indication is cognitive assessment while its commercial claim is amyloid and p-tau217 prediction, much of it in conference abstracts rather than full papers. Cognivue's weakness is deployment, dedicated hardware graded C with the weakest interoperability in the category. Neither publishes a security attestation or a BAA.