Regulatory aspects related to X-ray based 3D histology

Details

Supervisors

Kerckhofs, Greet ; Geens, Pierre

Faculty

Ecole polytechnique de Louvain

Degree label

Master [120] : ingénieur civil biomédical, à finalité spécialisée

Abstract

enHistology, the microscopic study of tissue architecture, is essential for biomedical research, diagnostics, and therapeutic development. While classical 2D histology remains the gold standard, recent advances have enabled non-destructive, three-dimensional imaging of tissues using microfocus X-ray computed tomography (microCT). To visualize soft tissues, specific sample preparation techniques such as contrast-enhanced microCT (CECT) and cryogenic CECT (cryo-CECT) have been developed, expanding the range of applications for this imaging approach. This thesis explores the regulatory framework applicable to these innovative histological services. Understanding the applicable regulations and quality standards is essential to support such a transition and it also identifies the potential market segments for these services.