OSLO: The Danish Medicines Agency (DMA) has authorised the clinical investigation «SWIS-02» in accordance with the executive order on medical devices.
The study is a confirmatory clinical investigation to document safety and performance og SoftOx Wound Irrigation Solution (SWIS) compared to Normal Saline (NS) in a human wound model.
This rapid approval by DMA is a major milestone for SoftOx and demonstrates the completeness and quality of our documentation and proposed investigational design, says Glenn Gundersen, Medical Director in SoftOx.
The clinical investigation, which is the final study for the SWIS medical device, may be initiated as soon as permission has also been granted by the relevant Scientific Ethical Committee.