Cognision

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.

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

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

• EEG ERP biomarkers
• Neurodiagnostic devices
• CNS clinical trials
• Cognitive assessment platform
• Alzheimer's diagnostic testing

Headquarters

HQ city

Louisville

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Supply Chain, Infrastructure, Marketing or Sales, Operations

Revenue model

1. 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.
2. 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.
3. 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.
4. 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

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core 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

Named customers7 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration11 records

AI capability4 records

Feature8 records

Partnerships

Ten partnerships are on record, tiered core and minor.

• KynexiscoreStrategic or Co-development Partner · 17 November 2025Cognision 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 ConsortiumcoreStrategic or Co-development Partner · 20 March 2019Founded 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.minorStrategic or Co-development PartnerPharma member of the ERP Biomarker Qualification Consortium. Founding principal member supporting ERP biomarker qualification studies for CNS drug development.
• Anavex Life Sciences Corp.minorStrategic or Co-development PartnerPharma member of the ERP Biomarker Qualification Consortium. Also engaged in separate Phase 2a trial (ANAVEX 2-73) using COGNISION System.
• H. Lundbeck A/SminorStrategic or Co-development PartnerPharma member of the ERP Biomarker Qualification Consortium supporting ERP biomarker qualification studies.
• Merck (MSD)minorStrategic or Co-development PartnerPharma member of the ERP Biomarker Qualification Consortium. Also sponsor of the 2023 EBS-B ketamine brain wave study.
• Sage TherapeuticsminorStrategic or Co-development PartnerPharma member of the ERP Biomarker Qualification Consortium supporting ERP biomarker qualification for CNS drug development.
• Takeda Pharmaceutical CompanyminorStrategic or Co-development PartnerPharma member of the ERP Biomarker Qualification Consortium supporting ERP biomarker qualification for CNS drug development.
• CenExel Hassman Research Institute (HRI)minorImplementation/ SI/ Consulting PartnerClinical 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)minorStrategic or Co-development PartnerNeuronetrix 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

Emerging 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

• LinkedInlinkedin.com/company/neuronetrix-inc

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds3 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cognision