Linus Health

The contrast with BrainCheck, also indexed, is the point of this grade. Linus Health does not digitise a paper test and score it; it analyses the drawing PROCESS, capturing temporal and spatial features of stylus manipulation across the entire act of drawing, plus speech and acoustic features, and derives metrics that have no paper equivalent. The LinusAD algorithm combines those behavioural features with age and APOE status to predict amyloid status. Remove the model and there is no product. This is the record that establishes what a genuinely AI-native cognitive assessment looks like in this index.

Positioned as a clinical aid producing provider reports for interpretation, with patient action plans and triage support rather than autonomous diagnosis. The FDA framing as a computerized cognitive assessment AID is explicit about the boundary. Reports include the actual clock drawing and recall recordings so a clinician can inspect the raw performance behind the score, which is a meaningful oversight affordance rather than a black box output. Graded B rather than A because the company does not publish how discordant cases are handled, specifically what a clinician should do when the algorithmic amyloid prediction and the clinical impression disagree, which is the decision point that matters most as this product moves toward treatment eligibility.

The methods are published in peer reviewed venues in genuine detail, including a Frontiers in Digital Health paper describing how the algorithms were developed, the resulting clinical scores and the validation findings, explicitly framed as clinically interpretable automated analysis of drawing behaviour. Published work names the specific feature classes used by the LinusAD algorithm: age, APOE status, drawing metrics, speech and acoustic features, and temporal-spatial features of stylus manipulation. Research is conducted under named IRB protocols with tracking numbers disclosed. That is a materially higher standard than the marketing-level description most vendors in the index offer.

Among the strongest evidence bases in the index, and critically it is largely INDEPENDENT rather than vendor-run. Massachusetts General Hospital and Harvard Aging Brain Study work published in Neurology found DCTclock significantly correlated with amyloid PET in cognitively normal individuals and outperforming the 30 minute Preclinical Alzheimer's Clinical Composite at differentiating amyloid positive from negative. A longitudinal study of more than 200 cognitively normal adults published in Annals of Clinical and Translational Neurology found higher amyloid and tau burden associated with faster DCTclock decline, particularly on processing speed and executive function. The Bio-Hermes-001 study evaluated 930 participants with 18F-florbetapir PET confirmation. An independent pilot in the population-based CARRS cohort in urban India tested 303 adults with 99.3 percent of tests yielding analyzable data. Validation therefore spans concurrent detection, longitudinal prediction, biomarker correlation and cross-cultural feasibility. The honest caveat: much of the amyloid prediction work appears as conference abstracts at AAIC and CTAD rather than full peer reviewed papers, and abstracts are not the same evidentiary weight.

The platform uses cloud-based analysis with real-time data synchronisation and captures audio recordings of patient speech alongside drawing data, making data handling material, but no published retention, de-identification or model training policy was located at the time of review.

No published BAA terms located at the time of review, notable given health system deployment with EHR integration.

No third party attestation such as SOC 2 Type II, HITRUST or ISO 13485 was retrieved at the time of review.

DCTclock is a Class II device described variously across sources as FDA cleared, FDA registered and FDA listed for marketing as a computerized cognitive assessment aid. Peer reviewed literature refers to it as FDA-cleared. Graded B rather than A for two reasons. First, the inconsistent terminology across the company's own materials and third party coverage, with no specific 510(k) number located, which is the same issue flagged on BrainCheck. Second and more important, a scoping gap that will grow: the regulatory status covers cognitive assessment, but the commercially significant claim is now amyloid and p-tau217 status PREDICTION, which is a different and more consequential intended use. Buyers should establish precisely which claims fall inside the cleared indication and which are research findings presented at conferences.

The best governance posture of any vendor added in this sweep, and rare in the index for being addressed rather than merely disclosed. A Linus Health clinical development lead stated publicly and unprompted that limited representativeness in the original training datasets can bias AI models when applied across differing cultural and educational contexts, naming the failure mode directly. The research programme then tests it: the Bio-Hermes-001 cohort of 930 participants was 56.8 percent female with 23 percent minorities, and reported as such. An independent pilot in the CARRS cohort in urban India examined performance in a South Asian population and published the uncomfortable finding as well as the reassuring one, that scores were significantly lower with older age and lower educational attainment while showing no difference by sex. Education and cultural effects are the central validity threat in cognitive testing, and this is a vendor publishing where its instrument is sensitive to them rather than concealing it.

EHR integration is offered as part of the health system workflow, with results and care coordination flowing into clinical and operational processes rather than living in a standalone portal. Graded B rather than A because no specific EHR vendors are named in located materials, unlike BrainCheck which names Epic and athenahealth explicitly.

iPad-administered with Apple Pencil, requiring a charged device and stable internet for real-time synchronisation and cloud-based analysis, with a remote administration capability marketed as Anywhere for Health Systems. Practical and demonstrably deployable in low-resource settings, evidenced by the India pilot achieving 99.3 percent analyzable tests. Graded B rather than A because the hardware dependency is real, requiring specific tablet and stylus hardware plus connectivity, which is a higher deployment bar than a browser-based product, and no data residency terms were published.

No pricing published and no pricing basis disclosed, and unlike BrainCheck there is no published reimbursement guidance naming applicable CPT codes. Given the same cognitive assessment billing codes should be available to health system customers, the absence of published guidance is a gap relative to the direct competitor in the same category.

Genuinely broad across settings and buyer types, which is unusual for a single clinical domain. Health systems with EHR-integrated workflows, primary care and specialist triage, remote and in-clinic administration, population and community brain health screening, and clinical trial recruitment where the value proposition is reducing screening failure rates and prescreening cost for disease modifying therapy trials. The suite of over a dozen assessments spans cognition, gait, speech and person-specific outcome measures, and the ePSOM work extends into trial endpoint design. Serving both clinical care and trial operations from the same instrument set is a materially wider footprint than any competitor located in this category.