FDA Class II Digital Cognitive Assessment

BrainCheck AssessTM

BrainCheck Assess is an FDA Class II digital cognitive assessment that provides standardized, repeatable measures of cognitive function to support clinician-led interpretation and care planning across primary care, neurology, geriatrics, behavioral health, and research.

By moving beyond purely subjective impressions, BrainCheck Assess gives clinicians structured cognitive data that can be interpreted alongside history, exam findings, and functional status, never in isolation.

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What BrainCheck Assess Does

BrainCheck Assess is the flagship assessment within the BrainCheck Platform. It delivers a standardized battery of digital cognitive tasks that evaluate multiple cognitive domains consistently and repeatedly.

The assessment is designed to support:

  • Early identification of potential cognitive impairment

  • Objective measurement of cognitive performance
  • Longitudinal monitoring of cognitive change over time

Clinicians can use BrainCheck Assess on its own or combine it with additional validated screeners and functional tools within the BrainCheck Platform when more context is needed.

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Where BrainCheck Fits in Clinical Workflows

BrainCheck Assess is used across a wide range of healthcare environments, including:
  • Primary care and Annual Wellness Visits
  • Neurology and memory clinics
  • Geriatrics and aging care
  • Behavioral health and psychiatry
  • Academic research and clinical trials
It is particularly valuable in workflows that require repeatable, longitudinal cognitive measurement rather than one-time screening alone.

Cognitive Domains Assessed

BrainCheck Assess evaluates key cognitive domains commonly impacted by neurological, psychiatric, and neurodegenerative conditions, including:

Attention
Memory
Mental flexibility
Processing speed
Executive function

Measure attention with Trails A and B

Trails A & B are widely used neuropsychological tests that measure visual search speed, scanning, processing speed, mental flexibility, and executive functioning. These tests provide insight into cognitive function in the frontal lobe, and also in the parietal and occipital lobe.

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Check memory with immediate and delayed recognition

Immediate and delayed recognition tests assess the ability to recognize previously seen items, determining function in the temporal, frontal, parietal, and occipital lobes.

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Assess mental flexibility with Trails B

Trails B is an established neuropsychological test that evaluates cognitive flexibility, attention, visual scanning, and memory by assessing ability to switch between numbers and letters while connecting circles in ascending order.

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Evaluate processing speed with Digit-Symbol Substitution

The Digit-Symbol Substitution test measures processing speed and accuracy. This proven test assesses function primarily in the frontal lobes.

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Evaluate executive function with the Stroop Color and Word test

The Stroop Color and Word test measures reaction time required to overcome cognitive interference. This proven test assesses function primarily in the frontal lobes.

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Attention

Measure attention with Trails A and B

Trails A & B are widely used neuropsychological tests that measure visual search speed, scanning, processing speed, mental flexibility, and executive functioning. These tests provide insight into cognitive function in the frontal lobe, and also in the parietal and occipital lobe.

Memory

Check memory with immediate and delayed recognition

Immediate and delayed recognition tests assess the ability to recognize previously seen items, determining function in the temporal, frontal, parietal, and occipital lobes.

Mental flexibility

Assess mental flexibility with Trails B

Trails B is an established neuropsychological test that evaluates cognitive flexibility, attention, visual scanning, and memory by assessing ability to switch between numbers and letters while connecting circles in ascending order.

Processing speed

Evaluate processing speed with Digit-Symbol Substitution

The Digit-Symbol Substitution test measures processing speed and accuracy. This proven test assesses function primarily in the frontal lobes.

Executive function

Evaluate executive function with the Stroop Color and Word test

The Stroop Color and Word test measures reaction time required to overcome cognitive interference. This proven test assesses function primarily in the frontal lobes.

FDA Regulation & Oversight

BrainCheck Assess is regulated as a Class II medical device by the FDA.

As part of this designation:

  • BrainCheck maintains an FDA-compliant quality management system
  • BrainCheck Assess is subject to FDA audits and regulatory oversight
  • Development, validation, and change-control processes follow FDA requirements

This regulatory framework ensures consistency, reliability, and clinical rigor in real-world use.

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Designed for Real-World Clinical Use

BrainCheck Assess is built for real-world clinical environments:

  • Digital administration on supported devices
  • Structured outputs that support documentation and follow-up
  • Suitable for in-clinic or supervised administration, depending on workflow

The platform is designed for efficient use by clinicians, staff, and patients while maintaining clinical rigor and clinical oversight.

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Understanding & Interpreting Results

BrainCheck Assess is designed to support clinical interpretation, not replace it.

Assessment results provide structured, objective data across multiple cognitive domains. Clinicians use this information to:

  • Compare performance across cognitive domains
  • Identify relative strengths and areas of concern
  • Establish a baseline for future comparison
  • Track change over time through repeat administrations

Results are presented in a clear, standardized format that supports:

  • Interpretation within the patient’s clinical context
  • Comparison against normative expectations
  • Longitudinal trend analysis rather than reliance on a single point-in-time score

BrainCheck Assess does not diagnose disease. Results are intended to inform clinical judgment and guide next steps such as further evaluation, referral, monitoring, or care planning, as determined by the treating clinician.

Scale, Adoption, & Real-World Use

Over the past 12 months, BrainCheck Assess has been administered more than 100,000 times, demonstrating:

  • Reliability at enterprise scale

  • Suitability for high-volume clinical workflows
  • Broad adoption across diverse care settings 

This real-world usage reinforces BrainCheck’s focus on practical, scalable cognitive care.

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Security, Privacy, & Compliance

BrainCheck operates in regulated healthcare environments and maintains:

  • HITRUST certification with ongoing audits
  • Support for HIPAA-compliant workflows
  • Execution of Business Associate Agreements (BAAs) with covered entities

These controls support secure handling of patient data across clinical deployments.

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Supporting Longitudinal Cognitive Care

BrainCheck Assess is designed to support ongoing cognitive care, not one-time testing. Repeated assessments enable clinicians to:

  • Monitor cognitive change over time

  • Identify meaningful trends or deviations from baseline
  • Inform follow-up evaluation, referrals, or care planning 

When used together with BrainCheck Digital Screeners and Care Plan, BrainCheck Assess helps clinicians move from early identification to structured assessment, documentation, and ongoing care planning within a single platform.

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Hear what our customers are saying

“As far as cognitive assessments go, BrainCheck is the best. It makes a lot more sense to me than the MoCA or MMSE, which tell you very little about patterns over time. The level of detail BrainCheck provides is superior and it provides equal value to providers and patients alike.”

Nathan Bell, MD
Medical Director, Frontier Psychiatry

“Neurologists are often tasked with managing an ever-increasing patient load with limited time and resources. BrainCheck has been pivotal in transforming how we approach these challenges, enhancing our efficiency and quality of care.”

Stacey Epps, MD
Executive Medical Director at Bon Secours Neuroscience Institute

“BrainCheck Assess offers a comprehensive evaluation, providing detailed insights into patients’ cognitive function. With results instantly available in athenahealth, these solutions make establishing a cognitive baseline and deploying subsequent assessments simple.”

Bruce Lowell, MD
Geriatrician and board-certified internist at New York Hospital Queens, North Shore Hospital Manhasset

“Using BrainCheck has been a positive experience and relief from the frustrations patients would previously express using other neurocognitive tests. The test is short and is easy to utilize, which makes a big difference. I personally feel it adds a lot of value to my assessment of a patient.”

Reuben Elovitz, MD
CEO & Internal Medicine Physician, Private Health Dallas

Your questions, answered.

Key things to know and discover about cognitive assessments.

Why is a cognitive assessment important for patients?

Cognitive assessments are crucial to empower early detection of cognitive impairment. Studies show a percentage of decline can be preventable by addressing modifiable risk factors and making simple lifestyle changes. Early intervention maximizes the window of opportunity and can significantly improve outcomes and quality of life.

How can providers assess cognitive function?

Traditionally, cognitive assessments have been conducted using paper and pencil tests, such as the Montreal Cognitive Assessment (MoCA) and the Mini Mental Status Exam (MMSE) – but digital solutions like BrainCheck Assess have revolutionized this process. Now, providers ranging from primary care to specialists can conquer the constraints of outdated assessments and easily evaluate patients’ cognition, on any device, in any location.

What information does a cognitive assessment provide?

Cognitive tests evaluate brain function to identify potential signs of impairment, but the insights provided may vary. To ensure accurate results, it is important to measure cognition comprehensively. BrainCheck Assess evaluates a range of key neurocognitive domains, including memory, attention, executive function, and mental flexibility. It highlights areas of strength and weakness, tracks changes over time, and helps guide clinical decisions with detailed, actionable insights.

What is BrainCheck Assess and how does it work?

BrainCheck Assess is a FDA Class II medical device that easily and objectively detects subtle signs of cognitive impairment. Leveraging clinically-validated digital versions of familiar screeners, it empowers providers to precisely measure performance across multiple cognitive domains – offering the most flexible and convenient solution.

Is BrainCheck Assess reimbursable?

Yes, BrainCheck Assess is fully reimbursable, enhancing practice profitability while improving patient care. The platform includes support for billing and reimbursement processes, ensuring that clinicians can provide high-quality cognitive assessments without financial barriers.

Ready to get Started?

A new, more accessible journey towards empowered and informed brain health awaits.

References

  1. Ye S, Sun K, Huynh D, Phi HQ, Ko B, Huang B, Hosseini Ghomi R. A Computerized Cognitive Test Battery for Detection of Dementia and Mild Cognitive Impairment: Instrument Validation Study. JMIR Aging 2022;5(2):e36825 doi: 10.2196/36825
  2. Groppell S, Soto-Ruiz KM, Flores B, Dawkins W, Smith I, Eagleman DM, Katz Y. A Rapid, Mobile Neurocognitive Screening Test to Aid in Identifying Cognitive Impairment and Dementia (BrainCheck): Cohort Study JMIR Aging 2019;2(1):e12615. https://doi.org/10.2196/12615c
  3. Huang B, Zavala P, Mann C, Harlock S, Dekle K, Knighton A, Ajtai B, Hemphill J. Implementation of BrainCheck for Cognitive Assessment and Care Planning in the Clinica Setting. Innov Aging. 2023 Dec 21;7(Suppl 1):917. doi: 10.1093/geroni/igad104.2946. PMCID:PMC10738837.
  4. Livingston G, Huntley J, Sommerlad A, et al. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020;396(10248):413–446. https://doi.org/10.1016/S0140- 6736(20)30367-6

Some feature availability determined by EHR integration.