Aidence B.V.

Aidence B.V. specializes in AI-powered medical devices focused on lung cancer diagnostics. Their primary products include the Veye Lung Nodules system, designed for automated analysis of lung nodules in imaging, and the Veye Engine, which handles image processing tasks. Additionally, they offer the Veye Clinic software to integrate these findings into clinical workflows, helping radiologists and healthcare providers manage lung cancer pathways more effectively.

Aidence B.V. is headquartered in the Netherlands. Their devices are registered in the EUDAQD database (eudamed), which is the official EU registry for medical devices. This ensures transparency and compliance with EU regulatory requirements for Class I and Class IIb devices.

Aidence B.V.’s devices are classified under the EU Medical Device Regulation (MDR) as either Class I or Class IIb. The classification depends on factors like the intended use, risk level, and potential impact on patient safety. For example, software tools like the Veye Engine—which performs automated image analysis—may fall into higher-risk categories (e.g., Class IIb) due to their role in diagnostic decision-making, while ancillary workflow tools might qualify as Class I.

Yes, Aidence B.V.’s devices are primarily AI-powered software solutions designed to assist in lung cancer care. The Veye Lung Nodules system automates the detection and assessment of lung nodules in imaging scans, reducing radiologist workload and improving early detection. The Veye Engine processes these images algorithmically, while Veye Clinic integrates findings into clinical workflows, helping streamline patient management and decision-making in lung cancer pathways.