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Beskrivning

LandSverige
ListaFirst North Stockholm
SektorHälsovård
IndustriMedicinteknik
Duearity är verksamt inom medicinteknik. Bolaget är specialiserat inom utveckling och produktion av tekniska lösningar för behandling och lindring av tinnitus. Produktportföljen inkluderar exempelvis bolagets egenutvecklade produkter Tinearity och Duearity. Utöver huvudverksamheten erbjuds även service och tillhörande kringtjänster. Verksamheten bedrivs inom Sverige.
2022-10-31 08:27:00

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.

Duearity 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.

- We assess that the US will become Duearity's most important market in the future. Tinnitus is a major problem in the United States and receives a great deal of attention, not least because many military personnel are affected. Therefore, it is a big and important step forward when we now apply for approval for sales in the USA, says Fredrik Westman, CEO of Duearity AB.

Duearity 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.