Pixyl

Pixyl specializes in AI-powered software tools that enhance MRI imaging analysis, with a focus on neuroimaging. Their primary product, Pixyl.Neuro, uses artificial intelligence to assist radiologists and clinicians in detecting and interpreting neurological features from MRI scans. These tools are designed to provide actionable insights to support diagnostic decision-making.

Pixyl is based in France and develops software-as-a-medical-device (SaMD) solutions. Since their devices fall under EU Class IIa classification, they must comply with European regulatory requirements, including registration in the EUDAMED database. This ensures their products meet the necessary safety, performance, and quality standards for use within the European Union.

Yes, Pixyl’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This listing confirms their compliance with EU regulatory requirements and provides transparency on their classification and regulatory status within the European market.

Pixyl’s devices are classified as EU Class IIa medical devices. This classification is determined based on factors like the intended use, potential risks, and the level of intervention in diagnostic processes. Class IIa devices require stricter regulatory oversight than lower-risk categories but do not pose the highest risk levels seen in Class IIb or III devices.