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Computerized Cognitive Assessment Aid, Exempt

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Name
Company Name
Description
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NeuroCatch Platform
NeuroCatch Inc
NeuroCatch Platform software NS20
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NeuroCatch Platform
NeuroCatch Inc
NeuroCatch Platform systemREF: NCP2
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NeuroCatch Platform
NeuroCatch Inc
Earbuds used for the NeuroCatch Platform (REF NCP2)
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NeuroCatch EEG Cap
NeuroCatch Inc
NeuroCatch EEG Cap, size Small for use with the NeuroCatch Platform system
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NeuroCatch EEG Cap
NeuroCatch Inc
NeuroCatch EEG Cap, size Medium for use with the NeuroCatch Platform system
0
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NeuroCatch EEG Cap
NeuroCatch Inc
NeuroCatch EEG Cap, size Largefor use with the NeuroCatch Platform system
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NeuroCatch Platform
NeuroCatch Inc
EEG Cap used for the NeuroCatch PlatformSizes SML, MED, LRG.
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Research Platform
Linus Health, Inc.
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Core Cognitive Evaluation
Linus Health, Inc.
Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It is intended to be used by medical professionals qualified to interpret results of a cognitive assessment.
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DCTclock
Linus Health, Inc.
DCTclock System
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DCTclock
Linus Health, Inc.
DCTclock System - Research
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DCTclock
Linus Health, Inc.
DCTclock Practice Test Form - clinical
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DCTclock
Linus Health, Inc.
DCTclock Test Form - Clinical
0
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DCTclock
Linus Health, Inc.
DCTclock Uploader Software
0
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DCTclock
Linus Health, Inc.
DCTclock Practice Test Form - Research
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DCTclock
Linus Health, Inc.
DCTclock Cloud Platform
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DCTclock
Linus Health, Inc.
DCTclock Micro USB Cable
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DCTclock
Linus Health, Inc.
DCTclock Dock
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DCTclock
Linus Health, Inc.
DCTclock Digital Pen
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DCTclock
Linus Health, Inc.
DCTclock Test Form - Research
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Floodlight MS Cognitive Test
Roche Molecular Systems, Inc.
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Floodlight MS Cognitive Test
Roche Molecular Systems, Inc.
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VRCBT
XR HEALTH IL LTD
The AT-910 ("A10tion") is a is a virtual reality, immersive therapeuticapplication, indicated to train and improve cognitive function of patients withdiagnosed ADHD. This application is a clinician- monitored program and should beconsidered for use as part of the therapeutic program that include clinician directedtherapyThis multidimensional training program application targetsattention, executive function and memory combined with motor activationthrough the use of games and entertainment features.
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VRCogni
XR HEALTH IL LTD
A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable guiding patients in the performance of various cognitive exercises, tracking and analyzing motion and movement kinematics and monitoring changes in patient's measurements over time.The CT-620 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-620 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device.
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VRCogni
XR HEALTH IL LTD
A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable guiding patients in the performance of various cognitive exercises, tracking and analyzing motion and movement kinematics and monitoring changes in patient's measurements over time.The CT-610 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-610 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device.
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Happyneuron Cognitive Training
HAPPYNEURON
The HappyNeuron Cognitive Training provides users with a program that is designed to be adapted for patientssuffering from cognitive impairments linked to chronic diseases. Two programs have been designed so fartargeting specific conditions: Multiple Sclerosis and Rheumatoid Arthritis.The cognitive training is a combination of scheduled workouts and on-demand complementary exercises.It contains computerized exercises that stimulate cognitive abilities (Memory, Attention, Language, ExecutiveFunctions and Visual-Spatial Skills). Coaching features guide the users through the exercises, adapt thedifficulty settings dynamically, and follow-up on performance.
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INTELLISPACE™ COGNITION
Philips Electronics Nederland B.V.
Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.
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INTELLISPACE™ COGNITION
Philips Electronics Nederland B.V.
Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.
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INTELLISPACE™ COGNITION
Philips Electronics Nederland B.V.
Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.
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INTELLISPACE™ COGNITION
Philips Electronics Nederland B.V.
Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.
0
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INTELLISPACE™ COGNITION
Philips Electronics Nederland B.V.
Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.
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INTELLISPACE™ COGNITION
Philips Electronics Nederland B.V.
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Cognitive Impairment Screener
IMPACT APPLICATIONS, INC.
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ANAM Test System
VISTA PARTNERS, LLC
The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain a more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions.The ANAM Test System provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test result to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Test System will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
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ANAM Test System: Military Battery
VISTA PARTNERS, LLC
The ANAM Test System: Military Battery (ANAM Military Battery) is a software only device that provides clinicians with objective measurements of cognitive performance in military populations, to aid in the assessment of an individual's level of cognitive function. The ANAM Military Battery provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions.The ANAM Military Battery provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test results to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Military Battery will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
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Speech Vitals - Cognition
Aural Analytics, Inc.
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Neurotrack Cognitive Assessment Battery
Neurotrack Technologies, Inc.
Neurotrack’s exam is a computerized cognitive exam delivered via mobile device or browser, intended to detect and track cognitive impairment in patients with existing cognitive impairment, subjective memory loss, or healthy individuals. The user will interact with the exam battery on a screen. Using visual cues, the user will touch the screen, trackpad or mouse to make a selection. Successful completion of the exam battery relies on use of the hands and eyes.The device may be used by the patient in the home, or in a health clinic with or without supervision. The results are reviewed by a health care provider trained in nervous system conditions. Neurotrack’s digital cognitive assessment suite is not a stand-alone diagnostic tool and does not identify the absence or presence of any illness, condition, or disease. While Neurotrack’s digital cognitive assessment suite can be self-administered, any interpretation of scores should be discussed with a healthcare provider.
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Cognition Snapshot+ 2.1.0
Qr8 Health Inc
0
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Cognition Chronicle
Qr8 Health Inc
0
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Chronicle Web
Qr8 Health Inc
0
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Cognition Snapshot v2.0
Qr8 Health Inc
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Cognition Snapshot
Qr8 Health Inc
0
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Brain Gauge MD
CORTICAL METRICS, LLC
The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
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Cognivue Thrive
COGNIVUE, INC.
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Cognivue Clarity
COGNIVUE, INC.
0
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Bertec Vision Trainer System (BVT)
BERTEC CORPORATION
The Bertec Vision Trainer System (BVT) is a device that objectively measures the performance of subject’s visuo-motor skills. It consists of a large touchscreen monitor, a force plate, and the BVT software. The subject interacts with the screen by touching and/or moving their center of pressure in response to a target stimulus, both dynamic and static.
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BITS Motion Sensor
BIONESS INC.
Bioness Integrated Therapy System Version 3.0 Motion Sensor
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Bioness Integrated Therapy System, BITS 3.0, BITS Balance
BIONESS INC.
BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
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Bioness Integrated Therapy System, BITS 3.0, BITS Balance
BIONESS INC.
Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
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Speech Vitals - Cognition
Aural Analytics, Inc.
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