Cognivue

A genuine middle case between BrainCheck and Linus Health, both indexed. Adaptive psychophysics is real computational adaptation: the test dynamically adjusts as the patient progresses, calibrating to that individual's visual and motor abilities, and collects over 130,000 data points to produce the score. That is substantively more than digitising a paper instrument, which is why this is not a C alongside BrainCheck. But it is an adaptive testing algorithm rather than a machine learning model deriving novel signal from behaviour, which is why it is not an A alongside Linus Health's analysis of stylus dynamics and speech acoustics. The company describes proprietary technology and a proprietary algorithm without claiming machine learning, which is accurate rather than inflationary and is worth noting in a category where AI language is applied loosely.

A on candour and scope discipline, the MD-Staff precedent. The company states plainly that Clarity and Thrive are indicated as ADJUNCTIVE tools for evaluating cognitive function, that they are not stand-alone diagnostic tools, and that they do not identify the presence or absence of clinical conditions. Placed in product copy rather than buried. There is an interesting structural inversion worth noting: the test is fully self-administered by the patient with no clinician proctor, which is MORE autonomous in administration than competitors, while the interpretation claim is more tightly constrained. Automating the administration and explicitly not automating the diagnosis is a coherent and well drawn boundary.

The mechanism is named specifically rather than behind an accuracy claim: adaptive psychophysics targeting cortical information processing, dynamic adaptation during the test, over 130,000 data points, and a single averaged output score derived from four perception and four memory subscores, with that output structure documented in the De Novo review file. Regulatory documentation being publicly retrievable is itself a transparency advantage. Graded B rather than A because the proprietary algorithm converting those data points into the clinical score is not described, and there is no published model card.

Strong, independent, and notably focused on the right question for this instrument class. A peer reviewed validation published in Neurological Sciences and Neurosurgery reported Cognivue as equally effective as the Montreal Cognitive Assessment with SUPERIOR test-retest reliability, which is the metric that actually matters for an instrument intended to establish a baseline and monitor change over time. Notably the company reports the correlation with MoCA honestly at r = 0.38, a modest figure it could easily have omitted or dressed up. The FOCUS study enrolled 452 participants across six US study sites, validating against RBANS, a gold standard battery used in both clinical practice and Alzheimer's trials, and separately established age-normed scores and measured practice effects. Original clearance rested on a large-scale 2014 comparison against standard neuropsychological tests. Evidence spans validity, reliability, normative range development and diverse population performance.

Dedicated hardware device generating an immediate one-page report, which implies a smaller data footprint than cloud platforms in this category, but no published data handling, retention or transmission policy was located at the time of review.

No published BAA terms or HIPAA posture statement located at the time of review.

No third party attestation such as SOC 2 Type II located at the time of review. Note that competitor Neurotrack publishes SOC 2 and HIPAA compliance prominently, so this is a disclosure gap relative to the category rather than an industry-wide absence.

The strongest regulatory position in this category and a category-creating one. Cognivue holds a De Novo classification, DEN130033, with the review documentation publicly available, validated against the St. Louis University Mental Status examination. A De Novo is not a 510(k): it establishes a new device classification where no predicate exists, meaning Cognivue created the regulatory pathway that subsequent computerized cognitive assessment devices were cleared into. This is the same distinction that earned Viz.ai an A for the first ever De Novo in computer aided triage, and it resolves an ambiguity across this whole category, where several vendors use cleared, registered and listed interchangeably. Both Clarity and Thrive operate under the same cleared technology, and the indicated use as an adjunctive tool is stated precisely.

The FOCUS study is among the most deliberate bias investigations by any vendor in the index, and it was designed for that purpose rather than reporting demographics incidentally. The published rationale states the problem directly: most cognitive instruments do not perform well in diverse samples of older adults, and because those same instruments gate clinical trial eligibility, they make recruiting minoritized adults into Alzheimer's studies harder. The paper quantifies the inequity it is responding to, noting that women are 50.4 percent of the US population but only 41.2 percent of clinical trial participants, and that 63 percent of US residents lack a bachelor's degree while 55.8 percent of trial participants hold a college or advanced degree. The study then enrolled 452 participants across six sites stratified by age, education, sex, race and ethnicity to calculate age-normed scores and assess performance across those strata. A vendor publishing the structural inequity in its own field and then testing its instrument against it is the benchmark this axis should be graded against.

No named EHR integrations located. The product generates an immediate one-page report at the device rather than flowing structured results into the clinical record. Against BrainCheck, which names Epic and athenahealth, Linus Health, which offers health system EHR integration, and Neurotrack, which claims integration with all EHRs, this is the weakest interoperability position in the category and reflects its origins as a standalone hardware device.

Dedicated hardware. Clarity and Thrive are physical devices rather than software on a tablet or browser, calibrated identically across units to ensure consistency. That calibration is a genuine reliability advantage and supports the superior test-retest finding, but it is also the most capital-intensive and least flexible deployment model in this category, requiring device purchase and physical placement, with no remote administration capability located. Compare Linus Health running on an iPad with a remote option, and Neurotrack claiming any device.

No device price or licence fee published, but the company states plainly that the assessment is patient-administered AND REIMBURSABLE, and the 5 minute Thrive product is explicitly positioned for pharmacy as well as office settings, which signals the intended billing and distribution model. Graded B rather than A because, unlike BrainCheck, no specific CPT codes or reimbursement guidance are published, and for a hardware product the acquisition cost is a material undisclosed variable that competitors selling software do not impose.

Two products deliberately sized for different settings, a 10 minute full assessment for clinical evaluation and a 5 minute screen for high-throughput environments including pharmacy, which extends reach beyond the physician office into retail health. Used across neurology, geriatrics and primary care, and the FOCUS validation against RBANS positions it for clinical trial screening as well. Graded B rather than A because coverage is a single clinical domain, cognition, and because the hardware requirement constrains where it can physically be deployed.