Cognision
Cognision (Neuronetrix Solutions, LLC) develops the FDA-cleared COGNISION EEG/ERP hardware system and Cognision360 cloud platform for objective cognitive biomarker assessment, serving physicians, pharmaceutical CNS trial sponsors, and academic researchers.
- Company typePrivate
- Founded2010
- HeadquartersLouisville, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Cognision does
Cognision, operating as Neuronetrix Solutions, LLC, is a Louisville, Kentucky-based neurodiagnostics company that builds FDA-cleared hardware and cloud software for objective measurement of brain function using quantitative EEG (qEEG) and event-related potential (ERP) biomarkers. Its core product, the COGNISION System, is a handheld, wireless 9-channel EEG/ERP device with active electrodes, Bluetooth data transfer, and a setup time of 5–10 minutes, designed so non-expert clinical staff can administer tests without certified electrophysiology technicians. The device was 510(k)-cleared in February 2015 and is CMS-reimbursable under multiple CPT codes, enabling adoption in routine physician offices rather than academic electrophysiology labs.
Layered on top of the hardware is Cognision360, a unified web-based SaaS platform launched in February 2026 that consolidates EEG, polysomnography, eye-tracking, cognitive assessments (via BrainCheck), wearable sensors, and electronic forms into a single trial data infrastructure with automated cleaning, tagging, and Bayesian adaptive trial support aligned with FDA guidance. The company monetizes the system through hardware sales and a monthly rental with no upfront cost for clinical use, study contracts with pharmaceutical sponsors running CNS trials (Alzheimer's, schizophrenia, depression), and recurring membership fees from the ERP Biomarker Qualification Consortium, a wholly owned subsidiary that counts 10 major pharma companies as members funding precompetitive EEG/ERP biomarker qualification.
The company's three primary customer segments are physicians and healthcare systems (memory disorder, concussion, and senior care clinics), pharmaceutical companies running CNS clinical trials, and academic/research institutions. Cognision also maintains strategic technology integrations with SOMNOmedics (sleep EEG/PSG) and BrainCheck (cognitive testing), and has been deployed in clinical research at sites including the University of Kentucky Sanders-Brown Center on Aging, Duke University, and Anavex's Phase 2a Alzheimer's trial in Australia.
Cognision firmographics
Firmographics- Name
- Cognision
- Legal name
- Neuronetrix Solutions, LLC
- Website
- https://cognision.com
- Company type
- Private
- Founded year
- 2010
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Cognision (Neuronetrix Solutions, LLC) develops the FDA-cleared COGNISION EEG/ERP hardware system and Cognision360 cloud platform for objective cognitive biomarker assessment, serving physicians, pharmaceutical CNS trial sponsors, and academic researchers.
- Ownership category
- akta.pro rank
Cognision industry classification
Industry- Product category
- Neurodiagnostic Devices and Biomarker Software
- NAICS
- Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345), Medical and Diagnostic Laboratories (62151)
- SIC
- Laboratory Analytical Instruments (3826), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Neurological Monitoring (EEG, Seizure/Sleep/Neuro Wearables) (HLAHACAE)
- akta.pro secondary industries
- Behavioral Health & Neurocognitive Therapeutics (Digital) (HLACANAI), eConsent & Digital Identity for Trials (HLACAOAE), Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)
Keywords
Where Cognision is headquartered
LocationHeadquarters
- HQ city
- Louisville
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Cognision business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Infrastructure, Marketing or Sales, Operations
Revenue model
- COGNISION System — Hardware Sales and Rental: The COGNISION hardware system is sold or provided under a monthly rental model with no upfront cost. Physicians and healthcare systems acquire the device for clinical use in evaluating cognitive disorders.
- Clinical Diagnostic Testing Services: The COGNISION System generates revenue through Medicare reimbursement under several CPT codes for EEG/ERP diagnostic testing sessions performed in physician offices and clinics.
- Cognision360 Platform — CNS Clinical Trial Services: Pharmaceutical companies engage Cognision for the use of Cognision360 in clinical trials, covering digital biomarker data acquisition, processing, and analysis across multiple modalities (EEG, PSG, eye-tracking, wearables). Revenue is derived from study contracts with pharma sponsors.
- ERP Biomarker Consortium Membership: The ERP Biomarker Qualification Consortium, a subsidiary of Cognision, is funded by membership fees from pharmaceutical companies (Merck, Novartis, AbbVie, Astellas, Lundbeck, Anavex, Sage, Alkermes, Neurocrine, Takeda) to perform precompetitive neuro-related studies.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Monthly | Monthly rental with no upfront cost for COGNISION System |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels5 records
Cognision product offering
Product offeringCore offering
Cognision develops and sells the FDA-cleared COGNISION® System, a portable wireless EEG/ERP headset that records and analyzes brain electrical activity for objective cognitive assessment in patients with disorders such as Alzheimer's disease, concussion/mTBI, and schizophrenia. The company also operates Cognision360™, a cloud-based unified biomarker platform used by pharmaceutical sponsors to consolidate EEG, polysomnography, eye-tracking, cognitive assessments, and wearable sensor data across multi-site CNS clinical trials, with automated analysis and support for Bayesian adaptive trial designs aligned with FDA guidance.
Product overview
Cognision offers a dual-product portfolio centered on neurophysiological brain function assessment. The core offering is the COGNISION® System, an FDA-cleared handheld wireless device that records EEG and event-related potentials (ERP) to measure cognitive function in clinical and research settings. Built on this core technology, Cognision360™ serves as the enterprise platform for pharmaceutical clinical trials, unifying data collection and analysis from multiple neurobiomarker modalities (EEG, PSG, eye-tracking, cognitive assessments, wearables) into a single cloud-based system with automated data analysis pipelines. The COGNISION® platform has been used in over 30,000 tests and supports both clinical diagnosis (concussion, dementia, Alzheimer's) and pharmaceutical drug development trials.
Differentiator
Problem solved
Functional benefit
Products and services
- COGNISION® System A handheld, wireless, FDA-cleared 9-channel EEG/ERP device (active electrodes at Fz, Cz, Pz, F3, P3, F4, P4, M1, M2) that records electrical brain activity via quantitative EEG (qEEG) and event-related potential (ERP) tests to produce physiological measures of cognitive function. Used in physician offices, memory disorder clinics, concussion/mTBI clinics, senior care facilities, and academic research settings to evaluate patients with cognitive disorders such as Alzheimer's disease, concussion/mTBI, dementia, and schizophrenia; available via monthly rental with no upfront cost and is CMS-reimbursable under multiple CPT codes.
- Cognision360™ A unified cloud-based SaaS platform that consolidates neurobiomarker data acquisition, processing, and analysis for pharmaceutical CNS clinical trials. Integrates EEG, polysomnography (PSG), eye-tracking, computer-based cognitive assessments (e.g., BrainCheck), electronic forms, and wearable/ambulatory device data (via WebUSB, WebBluetooth, WebHID, WebSerial APIs) into a single system with automated metadata tagging and near real-time pharmaco-statistics dashboards. Supports decentralized trial designs and Bayesian adaptive trial designs aligned with FDA guidance.
Quantifiable outcome
- COGNISION System correctly classified mild Alzheimer's patients from age-matched controls approximately 80% of the time in a 106-subject preliminary trial (target 200 subjects)
- +3 more outcomes
Companies that use Cognision
Customer profileNamed customers7 records
Segments4 records
Ideal customer profiles4 records
Cognision technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration11 records
AI capability4 records
Feature8 records
Cognision partnerships and signals
Strategic signalPartnerships
Ten partnerships are on record, tiered core and minor.
- KynexiscoreCognision partnered with Kynexis to use the COGNISION System in a Phase 2 clinical trial of KYN-5356 for subjects with schizophrenia. The trial aims to demonstrate the efficacy of KYN-5356 (a drug designed to improve cognitive impairment associated with schizophrenia) by utilizing EEG and ERP testing to measure brain function and neurophysiological biomarkers linked to cognitive changes.
- ERP Biomarker Qualification ConsortiumcoreFounded by Cognision as a subsidiary, the ERP Biomarker Qualification Consortium brings together pharmaceutical companies (Alkermes, Anavex, Cadent, Lundbeck, Merck, Neuronetrix/Cognision, Sage, Takeda) plus academic and regulatory advisors to formally qualify EEG/ERP biomarkers for schizophrenia drug development under FDA guidelines. The consortium runs precompetitive clinical studies to establish standardized ERP measurements.
- Alkermes, Inc.minorPharma member of the ERP Biomarker Qualification Consortium. Founding principal member supporting ERP biomarker qualification studies for CNS drug development.
- Anavex Life Sciences Corp.minorPharma member of the ERP Biomarker Qualification Consortium. Also engaged in separate Phase 2a trial (ANAVEX 2-73) using COGNISION System.
- H. Lundbeck A/SminorPharma member of the ERP Biomarker Qualification Consortium supporting ERP biomarker qualification studies.
- Merck (MSD)minorPharma member of the ERP Biomarker Qualification Consortium. Also sponsor of the 2023 EBS-B ketamine brain wave study.
- Sage TherapeuticsminorPharma member of the ERP Biomarker Qualification Consortium supporting ERP biomarker qualification for CNS drug development.
- Takeda Pharmaceutical CompanyminorPharma member of the ERP Biomarker Qualification Consortium supporting ERP biomarker qualification for CNS drug development.
- CenExel Hassman Research Institute (HRI)minorClinical research site for the ERP Biomarker Consortium's EBS-B ketamine brain wave study. HRI conducted 3-visit dosing sessions with 24 healthy subjects, administering sub-anesthetic ketamine doses and recording EEG/ERP data using the COGNISION System.
- Anavex Life Sciences Corp. (historical)minorNeuronetrix was selected by Anavex in 2014 to support a Phase 2a clinical trial for ANAVEX 2-73 (Alzheimer's disease) using COGNISION System to measure cognitive biomarkers. Trial enrolled 32 patients across up to 7 sites in Australia.
Scale indicators6 records
Recent moves6 records
Expansion highlights5 records
Cognision competitors and assessment
Company assessmentEmerging players
- iMotions: Biometric research platform aggregating EEG, eye-tracking, GSR, and facial coding for consumer neuroscience and academic research. Comparable to Cognision's multi-modal neurobiomarker approach for research and pharma applications.
- Wearable Sensing: Developer of wireless, dry-electrode EEG headsets for research and BCI applications. Comparable hardware positioning to Cognision's portable wireless headset, though primarily research-oriented rather than FDA-cleared clinical.
- EMOTIV: Consumer and research-grade wireless EEG headsets with cloud-based EEG data analysis. Overlaps with Cognision's portable EEG/ERP approach but skews toward consumer/research rather than FDA-cleared clinical use.
- NovaTech EEG: Clinical EEG hardware and software provider serving hospitals, physicians, and research labs. Comparable to Cognision in clinical EEG/ERP delivery with similar FDA-cleared positioning for office-based neurophysiology.
Broad incumbents
- ANT Neuro: Established European provider of EEG, MEG, and TMS systems for research and clinical neurophysiology. Competes with COGNISION in academic and pharma research labs, particularly for high-density ERP studies.
- Compumedics: Global manufacturer of clinical and research EEG/PSG systems, with strong presence in sleep diagnostics and CNS research. Comparable to Cognision's PSG/sleep EEG offering and competing for the same pharma clinical trial and hospital channels.
- Natus Medical: Established neurodiagnostic medical device company offering EEG, EMG, and PSG systems widely used in hospitals and clinics. Overlaps with Cognision in clinical EEG hardware and clinical neurophysiology workflows but operates at much larger scale across multiple modalities.
- Magstim: Provider of transcranial magnetic stimulation (TMS) and neuroscience research instruments including EEG. Comparable in neuroscience research customer base and CNS clinical applications, with overlapping pharma trial customers.
Regional players
- SOMNOmedics: German manufacturer of PSG and sleep EEG systems that is already a strategic partner integrating with Cognision360. Comparable in PSG/sleep biomarker capabilities and a natural competitor or co-dependency for sleep-focused CNS trials.
Direct peers
- BrainCheck: Digital cognitive assessment platform integrated within Cognision360 that provides computerized psychometric testing for attention, memory, and executive function. Direct competitor for the cognitive assessment portion of CNS trials and clinical cognitive evaluation.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Cognision social profiles
Digital presenceCognision compliance and trust
Trust signalCompliance1 record
Cognision financial estimates
Financial estimateRevenue estimate
Valuation estimate
Cognision leadership team
Management profileNumber of profiles
Profiles3 records
Cognision subsidiaries and ownership
Company hierarchySubsidiaries1 record
Cognision funding detail
Funding detailFunding overview
Funding rounds3 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Cognision M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Cognision
What does Cognision do?
Cognision develops and sells the FDA-cleared COGNISION® System, a portable wireless EEG/ERP headset that records and analyzes brain electrical activity for objective cognitive assessment in patients with disorders such as Alzheimer's disease, concussion/mTBI, and schizophrenia. The company also operates Cognision360™, a cloud-based unified biomarker platform used by pharmaceutical sponsors to consolidate EEG, polysomnography, eye-tracking, cognitive assessments, and wearable sensor data across multi-site CNS clinical trials, with automated analysis and support for Bayesian adaptive trial designs aligned with FDA guidance.
Is Cognision a public or private company?
Cognision is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Cognision founded?
Cognision was founded in 2010. It employs 11 to 50 people.
Where is Cognision based?
Cognision is headquartered in Louisville, United States, in the North America region.
How does Cognision make money?
Four revenue lines are on record. COGNISION System — Hardware Sales and Rental is the primary driver. The others are clinical Diagnostic Testing Services, cognision360 Platform — CNS Clinical Trial Services and ERP Biomarker Consortium Membership.
Who are Cognision's main competitors?
Emerging players on record are iMotions, Wearable Sensing, EMOTIV and NovaTech EEG. Broad incumbents are ANT Neuro, Compumedics, Natus Medical and Magstim. SOMNOmedics is listed as a regional player. BrainCheck is listed as a direct peer.
Does Cognision have an API?
No public API is recorded for Cognision.
What industry is Cognision in?
Cognision's product category is Neurodiagnostic Devices and Biomarker Software. Its primary akta.pro industry code is HLAHACAE, Neurological Monitoring (EEG, Seizure/Sleep/Neuro Wearables), with a secondary code of HLACANAI, Behavioral Health & Neurocognitive Therapeutics (Digital). Its NAICS code is 33451 and its SIC code is 3826.