Frequently Asked Questions
General Overview of Theia
Theia is an AI-powered tool that helps healthcare professionals assess the risk of Mild Cognitive Impairment (MCI) in patients. It uses functional Near-Infrared Spectroscopy (fNIRS) to measure real-time changes in brain blood flow, and applies machine learning algorithms to generate a score indicating the likelihood of MCI.
Clinical trial. 2024 Data on file, Newmanbrain.
Theia is intended to measure relative changes in the concentration of oxygenated (HbO) and deoxygenated (HbR) hemoglobin in the prefrontal cortex, as an aid in identifying the functional cortical response of subjects with mild cognitive impairment (MCI). It is designed as an adjunctive pre-screening tool for adults aged 60 to 85 years and is not intended to be used as a stand-alone diagnostic device.
Newmanbrain technology can benefit:
Patients who wish to understand their cognitive health.
A wide array of healthcare providers (neurologists, psychiatrists, psychologists, gerontologists, nurses…).
Researchers and pharma, aiming to understand cognitive health, are providing data that may be used in research on brain-drug interactions.
Companies building AI-powered health solutions that may be interested in assessing or understanding cognitive health.
Yes, Theia is a CE-marked medical device class IIa, certified under Regulation (EU) 2017/745 (MDR) by IMQ, a European Notified Body (No. 0051). Newmanbrain also holds a medical device manufacturer licence and operates under an ISO 13485:2016-certified quality management system. Theia is designed for clinicians, researchers, and other healthcare professionals to assess cognitive health using functional near-infrared spectroscopy (fNIRS), combining rigorous regulatory compliance with award-winning design.
Technology and AI-Powered Features
Theia uses functional Near-Infrared Spectroscopy (FNIRS) to detect changes in oxy-hemoglobin (HbO) and deoxy-hemoglobin (HbR) levels in the prefrontal cortex during simple cognitive tasks. These measurements are analyzed through AI algorithms to generate a score that reflects the likelihood of MCI. Check out our “Science” page to learn more.
Theia leverages machine learning algorithms to analyze functional Near-Infrared Spectroscopy (fNIRS) data, comparing it against a database of patterns associated with Mild Cognitive Impairment (MCI) and healthy cognitive states. This AI-driven approach provides an objective and accurate assessment of cerebral hemodynamics.
Clinical trial. 2024 Data on file, Newmanbrain.
Clinical Pathway and Integration
Montreal Cognitive Assessment (MoCA) or Mini-Mental State Examination (MIS), are subjective and time-consuming. Theia provides an objective and fast assessment (under 20 minutes).
Data on file, Newmanbrain.
Theia is an accurate pre-assessment tool for Mild Cognitive Impairment (MCI) that helps clinicians determine the next steps in the diagnostic process.
Clinical trial. 2024 Data on file, Newmanbrain.
By offering a fast, accurate, and objective MCI assessment, Theia streamlines the diagnostic process, helping to identify individuals at risk for MCI.
Clinical trial. 2024 Data on file, Newmanbrain.
Theia supports early detection of Mild Cognitive Impairment (MCI), which is crucial for preventing or slowing the progression to dementia.
Yes, Theia is portable and can be used in various settings, including hospitals, outpatient clinics, and physicians’ offices.
Clinical Validation and Performance
Yes, Theia has undergone clinical validation through a study conducted in 2024, which demonstrated high sensitivity, specificity, and predictive value. The device successfully differentiated between MCI patients and healthy individuals with high accuracy. The device is intended to provide adjunct information to established cognitive assessments and is not intended to provide a stand-alone diagnosis for MCI.
Clinical trial. 2024 Data on file, Newmanbrain.
Theia showed:
- Sensitivity: 75%
- Specificity: 94%
- Positive Predictive Value (PPV): 92% (with 50% MCI prevalence)
- Negative Predictive Value (NPV): 94% (with 18% MCI prevalence)
- Area Under the Curve (AUC): 92.6%
These results indicate excellent performance in distinguishing MCI from healthy individuals. Nevertheless, Theia is not intended to provide stand-alone diagnosis for MCI. Currently, no diagnostic test or technique on the market can be used alone to diagnose MCI or dementia.
Clinical trial. 2024 Data on file, Newmanbrain.
Botello-Marabotto M, Martínez-Bisbal MC, Calero M, et al. Non-invasive biomarkers for mild cognitive impairment and Alzheimer’s disease. Neurobiology of Disease. 2023;187(106312). doi: https://doi.org/10.1016/j.nbd.2023.106312
Theia demonstrated a high accuracy in detecting Mild Cognitive Impairment (MCI), with a sensitivity of 75% and specificity of 94%. Literature suggests Theia may offer improved sensitivity/specificity compared to current neuropsychological tests in identifying MCI.
Clinical trial. 2024 Data on file, Newmanbrain.
Device Specifications and Usage
Theia is intended for use in adults aged 60 to 85 years, the age group with the highest prevalence of Mild Cognitive Impairment (MCI).
The test typically takes under 20 minutes, making it a quick and efficient tool for healthcare providers.
Data on file, Newmanbrain.
Theia is designed to facilitate broad patient participation in clinical trials by using simple arithmetic tasks that require only basic reading skills, making it accessible to individuals with diverse educational backgrounds.
The patient wears a lightweight, non-invasive headset and completes a series of simple tasks while sitting on a chair. It is non-invasive, fast, and hustle-free as the patient does not need to wear gels on the scalp or be in claustrophobic environments.
Regulatory and Compliance Considerations
Yes. Theia is CE-marked as a medical device under the EU Medical Device Regulation (MDR 2017/745), with certification issued by IMQ, a European Notified Body (No. 0051). Newmanbrain also holds a medical device manufacturer licence and maintains an ISO 13485:2016-certified quality management system, ensuring the highest standards of safety, traceability, and quality throughout design, manufacturing, and post-market monitoring.Theia is not currently FDA-approved. A regulatory pathway for the US market is under evaluation, and we will share updates as this progresses.
Theia protects patient information through encryption, strict access controls, and continuous monitoring, in full compliance with GDPR. As a CE-marked medical device certified under the EU MDR 2017/745, Theia is manufactured under an ISO 13485:2016-certified quality management system — ensuring that data protection, traceability, and device safety are managed to recognized international standards throughout the entire product lifecycle.
Theia is CE-marked under the EU MDR 2017/745, so it can be used in clinical practice within the European Union and in other markets that recognize CE marking. In countries that require their own approvals (for example, FDA clearance in the United States), availability is subject to obtaining the corresponding regulatory authorizations. Get in touch with us to discuss your needs, or check our plans to get started.
Usage and requirements
Theia requires the installation of its application on a computer that meets the minimum system requirements. You can use an existing PC, as long as it is compatible. If your current setup doesn’t meet the requirements, a new computer will be needed to ensure optimal performance. If you need more information about system requirements, please contact us.
Although Theia is an easy-to-use platform, a little extra hand on how to get started is always welcome. We offer clear instructions during the patient’s evaluation and a detailed user manual in case you want to check the full documentation for more details.
Purchases, subscriptions and Payment options
Theia is CE-marked and available in the EU/EEA through our subscription plans, designed to give clinics and researchers flexible access to the device, software, and ongoing support. Get in touch with us to discuss your needs, or check our plans to get started.