PolarCool takes an important step towards launching in the US
The med-tech company PolarCool AB (publ.) announces that today they have submitted a formal De Novo application to the US Food and Drug Administration (FDA), to prepare for a launch in the USA. The company announces today that a De Novo-application for the PolarCap® System has been submitted to the FDA. This is an important step ahead of the upcoming company launch in the United States, where the goal is to initiate a full-scale investment in the US American market in 2025-2026. The company already has an employee stationed in the US with the task of preparing the launch. A market