Duearity will submit an application for so-called 510(k) clearance by end of November 2022. An FDA approval will allow the company to sell Tinearity G1 in the US. The company has also started building a local sales and market organization.

The company has almost completed the work on the technical file to be submitted to the FDA in the US at the end of November and thus apply for 510(k) clearance. The goal is to get an approval at the end of the first half of 2023 and thus be given the permission to sell Tinearity G1 on the American market. The company has the started work on building an organization in the US that will handle marketing, sales and distribution.

The goal is for an organization to be in place during the first quarter of 2023.