Technology transfer of optical guidance system for neurosurgery

Purpose and goal:

This project aims to evaluate market, production and regulatory eligibility requirements to commercialize a medical device for optical guidance in neurosurgery. The product is tested within research collaborations and a goal of the project is technology transfer to FluoLink, the company formed to commercialize the medical device in order to produce a product that is market approved under the medical device regulations.

Collaborators from Linköping University, Region Östergötland and FluoLink are involved in the project. Expected results and effects: The project intends to verify market potential, evaluate eligibility requirements on the end product in terms of procurability, regulations for CE marking and standards, and build a fifth generation of

prototype. This prototype is intended to be equivalent to the final product and take the project a bit towards commercializing the product. Within the project, the prototype must be documented according to the regulation for medical devices as part of preparing and planning a clinical evaluation before CE marking

Approach and implementation: The work is carried out in four work packages: *Project management *Production of prototype 5 *Feasibility study *Preparations for clinical trial for CE marking