Netherlands-based artificial intelligence (AI) firm Aidence has been granted the CE Mark for Veye Chest, the company's lung nodule management assistant software.
The approval was one of the first under the European Union's new Medical Device Regulation (MDR) process, according to Aidence. Established in 2017, the new MDR requires medical devices labeled as class IIA or higher to reapply for the CE Mark.
The Veye Chest AI software automatically detects, classifies, and tracks the growth of nodules on chest CT scans. Regulatory clearance for the program required strong risk management, clinical data, and postmarket clinical follow-up, according to Aidence.
The new certification classifies Veye Chest as a class IIB medical device, instead of the previous IIA classification. The software is currently deployed at multiple sites in Europe for routine clinical practice and screening.
