In a coordinated effort among academia, clinical and industrial partners, the project will address both regulatory and technical aspects to: (i) generate the necessary documentation to comply with GSPR/EU-MDR; (ii) scale-up the manufacturing readiness level of silicon-based gratings, i.e. the key components within a GI-BCT device (iii) deploy the necessary system development and advanced image processing to push the GI-BCT technology to breakthrough into the regime of clinical dose.