A notified body is an independent third party appointed by a competent authority to verify that the product is safe from a clinical, safety and user perspective. The CE mark verifies a company's clinical claims that a product meets the essential requirements of the Medical Devices Regulations (MDR), and it is a legal requirement for a product to be sold on the market within the EU. TÜV's evaluation is expected by the company to be completed during the first quarter of 2023. After obtaining the CE mark, the product will be available for sale in Europe.

CoreTherm® Eagle is an updated and modernized platform for performing ProstaLund's treatment of benign prostatic enlargement, CoreTherm® Concept. CoreTherm® Eagle combines the proven and well-documented technology from previous CoreTherm® platforms with a newly developed, simplified, and modern user interface and software updates in order to provide improved method support for treating physicians and increased safety for treated patients.

“The development work of CoreTherm® Eagle began long before I arrived at ProstaLund and after a re-start in the spring of 2020, it feels incredibly nice that we have now reached this milestone. This is a very important piece of the puzzle to be able to take CoreTherm® towards a wider use and we will now have full focus on planning and preparing for the launch of CoreTherm® Eagle.” comments CEO Johan Wennerholm