Cortechs.ai expanded its European CE marking under the European Union Medical Device Regulation for Version 5 of NeuroQuant, including NeuroQuant, NeuroQuant MS and NeuroQuant ARIA, as well as NeuroQuant Brain Tumor and OnQ Prostate.
The company claims the expanded certification confirms these products meet EU MDR standards for safety, performance and quality and enables commercialization throughout the European Economic Area.
The move is intended to support broader European commercialization and to establish a scalable regulatory framework for future platform growth across neurology, neuro-oncology and prostate imaging.
The company states that the updates bring automated brain segmentation, volumetric analysis, longitudinal tracking, and restriction spectrum imaging-based prostate mapping to its unified AI-powered quantitative imaging platform, and that regulatory, clinical, and engineering investments have positioned the organization to achieve the expanded certification.
The company says it will continue advancing platform capabilities for clinicians and researchers while pursuing international market expansion.
