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Technology transfer of optical guidance system for neurosurgery

Reference number
Coordinator FluoLink AB
Funding from Vinnova SEK 3 000 000
Project duration April 2024 - March 2026
Status Ongoing
Venture Swelife - Collaboration project for better health
Call Swelife - Collaborative projects for better health autumn 2023

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 effects and result

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

Planned 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

External links

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 29 April 2024

Reference number 2023-03943