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