Novel ultrasound-based software to predict stroke and myocardial infarction
| Reference number | |
| Coordinator | Region Skåne - Skånes Universitetssjukhus SUS, Malmö |
| Funding from Vinnova | SEK 1 676 000 |
| Project duration | May 2020 - February 2023 |
| Status | Completed |
| Venture | Swelife and Medtech4Health - Collaborative Projects for Improved Health |
Important results from the project
We are developing an ultrasound technique that can be used to detect individuals at risk to suffer from a stroke or a myocardial infarction. The aim of the project was to optimize further details of the method, to evaluate it clinically in patients, as well as investigate and evaluate business and regulatory plans. The project has been successful in many aspects, but the clinical evaluations have been challenged by the COVID19 pandemic and the MDR regulation, and not fully finalized yet.
Expected long term effects
The project has resulted in an improved method that is protected by a patent application. The novel method has been evaluated ex vivo and in vivo with encouraging results. However, results of two of the clinical studies are not finished yet due to pandemic delays. The business model has been revisited several times during the project and a regulatory plan for the coming company has been formed. Next steps are to start a company, create a quality management system and build a first prototype.
Approach and implementation
Even if not all sub-goals have been fulfilled yet, the project has been successful as some of the sub-goals surpassed our expectations, particularly technically where we made a paradigm shift in ultrasonic frequency analysis. Very successful for the project has been the multidisciplinary gathered competence. The main hurdles have been external as the COVID19 pandemic and the new medical device regulation, which delayed some of the planned clinical studies.