BrainCheck vs Cognivue
Two of the most credible records in cognitive assessment, split by regulatory weight against practical fit. Cognivue is the category's originator: it holds the De Novo classification that created the regulatory pathway every later computerised cognitive test was cleared into, its adaptive psychophysics is genuine computation rather than a digitised paper test, and its FOCUS study is among the most deliberate bias investigations by any vendor in this index. What it costs you is flexibility, since Clarity and Thrive are dedicated calibrated hardware with no remote option and no named EHR integration. BrainCheck is the more deployable and commercially transparent choice: it runs on any tablet with proven remote equivalence, names the exact CPT codes and reimbursement path openly, and integrates with Epic and athenahealth, at the cost of being a normed digital battery rather than a model. If your failure mode is regulatory defensibility and demographic validity, start with Cognivue. If your failure mode is deployment friction and getting the workflow reimbursed, start with BrainCheck.
- The reimbursement path is published, not gated: BrainCheck names the specific CPT codes including 96136, 96138, 96132, and 99483, the 16 minute minimum for time based codes, and telehealth eligibility, in an annually updated guide, graded A on commercial transparency where Cognivue publishes no code level guidance and grades B.
- Flexible delivery with evidence behind it: runs on any tablet or smartphone, in clinic or remote, and a published finding that remote self administration is statistically indistinguishable from coordinator led sessions, where Cognivue requires dedicated calibrated hardware and grades C on deployment.
- Named EHR integration: live links to Epic and athenahealth with results in the chart, graded B on interoperability, where Cognivue generates a one page report at the device and grades C.
- The regulatory foundation of the category: Cognivue holds the De Novo classification DEN130033, the first FDA cleared computerised cognitive test, which created the pathway later entrants were cleared into, graded A on regulatory status where BrainCheck grades B on inconsistent cleared, registered, and approved language.
- More than a digitised battery: adaptive psychophysics dynamically calibrates to each patient's visual and motor abilities across more than 130,000 data points, graded B on AI centrality where BrainCheck's normed digital battery grades C.
- 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 where BrainCheck grades B without a subgroup breakdown.
Side-by-Side
| Axis | B BrainCheck |
C Cognivue |
|---|---|---|
| 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 |
Both are strong, candid records: each grades A on autonomy for prominently stating it is an adjunctive tool and not a stand alone diagnostic, and each reports its own unflattering numbers, BrainCheck the weaker 64 percent true positive rate for the MCI group, Cognivue its modest r=0.38 correlation with the MoCA. Both grade A on clinical evidence from independent, peer reviewed validation. The split is structural: Cognivue is the regulatory originator with the stronger bias study but the most capital intensive deployment, dedicated hardware with no remote option; BrainCheck is the more flexible and commercially legible product but a digitised battery rather than a computational model. Neither publishes a security attestation such as SOC 2 or a BAA. Neither publishes a device or licence price.