A milestone that validates the safety, effectiveness, and quality of the company’s medical device
Newmanbrain has obtained certification under the European Union Medical Device Regulation (MDR) for Theia, its innovative medical device designed for brain activity assessment and the early detection of cognitive impairment. This achievement represents a major milestone for the company and reinforces its commitment to developing advanced healthcare technologies that improve clinical decision-making and patient outcomes.
The MDR certification is one of the most demanding regulatory standards for medical devices worldwide. Its purpose is to ensure that medical devices marketed within the European Union are safe, effective, and clinically validated throughout their entire lifecycle.
Certification that guarantees safety and clinical performance
The certification confirms that Theia meets the European Union’s strict requirements regarding safety, quality, and clinical performance. It also validates the company’s quality management systems, post-market surveillance processes, and the scientific evidence supporting the device’s intended use.
Furthermore, the certification process demonstrates that Newmanbrain has identified, assessed, and mitigated potential risks associated with the device, ensuring its safe use in clinical environments and compliance with European regulatory standards.
This recognition provides greater confidence to healthcare professionals, medical centers, and research institutions seeking innovative solutions to enhance brain health assessment and cognitive screening.
Theia: Innovation applied to neuroscience
Theia is an advanced solution developed by Newmanbrain that combines functional neuroimaging, artificial intelligence, and advanced data analytics to provide objective insights into brain activity.
Its technology enables non-invasive, rapid, and accessible assessments, helping clinicians identify early signs of cognitive decline before symptoms become more evident. By supporting the early detection of cognitive alterations, Theia contributes to more informed clinical decisions and earlier interventions.
Thanks to its portable design and ease of use, Theia brings advanced neurodiagnostic capabilities closer to hospitals, clinics, and specialized healthcare centers.
Newmanbrain’s commitment to biomedical innovation
Newmanbrain is a company focused on the development of software and hardware solutions for biomedical applications in the fields of neuroscience and biomedicine. Since its foundation, the company has been dedicated to transforming cutting-edge scientific research into innovative technologies that support healthcare professionals in the assessment and monitoring of brain health.
The company is backed by a highly experienced team of scientists and entrepreneurs. Newmanbrain was founded and is driven by Carlos Belmonte, former Director of the Institute of Neurosciences—a joint center of the Miguel Hernández University of Elche (UMH) and the Spanish National Research Council (CSIC)—and Emeritus Professor at UMH; Joaquín Ibáñez, Director of the Department of Physiology at UMH; and Pablo Belmonte, Chief Executive Officer of Newmanbrain.
By combining internationally recognized expertise in neuroscience, physiology, and technology innovation, the company has built a strong scientific foundation for the development of solutions such as Theia, designed to bring advanced neurodiagnostic tools into clinical practice.
This multidisciplinary approach allows Newmanbrain to bridge the gap between scientific discovery and healthcare innovation, contributing to the advancement of brain health assessment, early cognitive impairment detection, and evidence-based medicine.
Advancing the future of brain health
The MDR certification of Theia marks the beginning of a new chapter for Newmanbrain. This achievement not only validates the quality, reliability, and safety of the technology but also creates new opportunities for growth within the European healthcare market and beyond.
By obtaining this certification, Newmanbrain strengthens its position as an innovative MedTech company, reaffirming its mission to transform brain health assessment through cutting-edge technology, artificial intelligence, and evidence-based innovation.
As the demand for early detection and prevention of neurological disorders continues to grow, Theia is positioned to play a key role in supporting healthcare professionals and advancing the future of precision medicine, cognitive health, and neuroscience-driven care.