After intensive development work, as well as passing safety tests carried out by an independent test house, Carbonhand 2.0 is now approved as a medical technical assistive device according to current regulations in Europe. In order to obtain this approval, Bioservo has worked for a long period with solid quality certification work according to ISO13485, and during the development work of the new generation of Carbonhand ensured that all applicable standards in the field are complied with.
Bioservo can now start sales to distributors and end users within the EU as well as the countries that accept UE-MDR as a regulatory approval in their market. In the Swedish market, the company conducts direct sales, and in other markets in In Europe, the company works via specialized distributors with relevant expertise and market presence.
Bioservo currently has distributors in Norway, Germany, France and Switzerland and continues to gradually expand the sales network to more markets in Europe. The grip-strengthening glove Carbonhand from Bioservo gives people with reduced hand function extra strength and endurance in their grip. Sensors in the fingertips register when the user grips an object, the system calculates how much force to add and pulls on artificial tendons that go out into the fingers of the hand and add force to the user's grip. The system learns what the user does and adapts the behavior to the user's needs.
"The fact that Carbonhand now is approved and becoming available in Europe is a big step both for us as a company and for all the people who live with impaired hand function around the world." says Petter Bäckgren, CEO at Bioservo and continues, "our next step is to make Carbonhand available also to everyone with impaired hand function in the US, preparations are underway and our goal is for it to take place as early as next year.
REHACARE.com; Source: Bioservo Technologies AB
