BrainCheck vs Cognivue (2026)
Both sell digital cognitive assessment, and both rest on the same FDA classification for computerized cognitive assessment aids. BrainCheck Assess is a standardized battery of digital tasks covering memory, executive function, attention, mental flexibility and processing speed, listed as a Class II exempt device and positioned as an aid to assessment rather than a standalone diagnosis, with care planning built around the result. Cognivue runs self administered tests on dedicated devices: Cognivue Clarity, about ten minutes, for physicians, and Cognivue Thrive, about five minutes, for pharmacies, hearing care practices and other settings, using adaptive exercises entered through a single control wheel. FDA created the classification with the original Cognivue device's De Novo authorization. Choose BrainCheck for assessment tied to care planning in a practice; choose Cognivue for a self administered screen on dedicated hardware, including outside physician offices.
- You want cognitive assessment and care planning in one platform.
- The test should cover memory, executive function, attention, flexibility and processing speed.
- Results should feed a care plan for the patient.
- Patients should take the test themselves on a dedicated device.
- You screen in pharmacies, hearing care or other settings outside a physician's office.
- A five minute screen suits your setting as well as a ten minute test.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. BrainCheck and Cognivue 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 | BrainCheck | Cognivue |
|---|---|---|
| Primary category | Clinical Decision Support | Clinical Decision Support |
| Founded | 2015 | Not recorded |
| Headquarters | Austin, Texas, United States | Victor, New York, United States |
| Website | braincheck.com | cognivue.com |
Side by Side
Select any grade to read the note behind it.
Product updates
The latest logged changes from each vendor, newest first, each linked to its source.
BrainCheck
-
Product / capability
BrainCheck added BrainCheck Screen, a pre screening tool that identifies which patients need fuller cognitive testing.
Source
Each vendor in one paragraph
Written to be quoted whole. Each paragraph opens the AI Health Index profile of the vendor: what the product is, who buys it and what it does.
Digital cognitive assessment and care planning platform. The flagship product, BrainCheck Assess, is a Class II, 510(k)-exempt computerized cognitive assessment aid regulated by the FDA, indicated as an aid in the assessment of cognitive impairment and explicitly not intended as a standalone diagnostic tool.
Source: AI Health Index, September 2026
Self-administered computerized cognitive assessment on dedicated devices. Cognivue Clarity, a ten minute test for physicians, and Cognivue Thrive, a five minute screen for pharmacies, hearing care practices and other non-physician settings, run on adaptive psychophysics: each exercise adjusts to the patient's visual and motor responses across subtests of memory, executive function and attention, discrimination and visuospatial ability, entered through a single control wheel, and the device prints a report scored against age norms.
Source: AI Health Index, September 2026
Questions buyers ask
How do BrainCheck and Cognivue work with the EHR?
For BrainCheck, the named list stops at those two, and the company notes some feature availability is determined by EHR integration, meaning capability varies by platform.
With Cognivue, the earlier security features document (RES-001-A, 2023) says an administrator can configure the device to create an HL7 message holding the report, or set up a password protected network file share to reach the report folder. The current Gen5 document (RES-002-A, 2025) mentions only printing, by USB or network. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
How do BrainCheck and Cognivue handle patient data?
Assessment data is handled under role based access controls with activity logging, encrypted in transit and at rest, and BrainCheck states that retention and deletion can be aligned to customer contractual requirements.
For Cognivue, the Gen5 security features document (RES-002-A, 2025) lists the fields Clarity and Thrive store per test: name, date of birth, sex, subtest and domain scores and, optionally, email and phone number. It says they are kept in a local database on the device, reachable only by on-device processes, under full disk AES-256 encryption, with administrators alone able to open older reports. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
What evidence is published for BrainCheck and Cognivue?
With BrainCheck, a later analysis found a Pearson correlation of 0.77 against the Montreal Cognitive Assessment with a confidence interval reported. A 529 participant study across four United States clinical sites, run with BrainBox Solutions and registered as NCT04423198, tested test retest reliability and concurrent validity against the corresponding paper instruments.
The authors are the company's Chief Scientific Officer, university colleagues and Cognivue staff. A competitor's analysis of the same Bio-Hermes cohort (Jannati et al., Alzheimer's Research and Therapy, 2025) reported Cognivue at AUC 0.70 for amyloid status, and the company's chief executive published a Matters Arising on that comparison's method (2026). From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
How much do BrainCheck and Cognivue leave to the clinician?
For BrainCheck, the company states that the assessment is not intended for use as a standalone diagnostic tool, that it is designed to support clinical interpretation rather than replace it, and that structured cognitive data is meant to be read alongside history, examination findings and functional status rather than in isolation.
With Cognivue, every product page states that Clarity and Thrive are adjunctive tools for evaluating cognitive function, not stand-alone diagnostic tools, that they do not identify the presence or absence of clinical diagnoses, and that results are to be interpreted by a licensed clinician. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
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.
Both records were reviewed on this site in September 2026. Neither publishes a price. Both products are listed with FDA as Class II exempt computerized cognitive assessment aids, not cleared through 510(k), and both are aids to assessment rather than diagnoses.
Ask both how their results compare with a full neuropsychological evaluation, and in which populations.