Carbonhand 2.0 approved as a medical device according to the EU-MDR
For people with impaired hand function, a new aid is now coming onto the market. The grip-strengthening glove Carbonhand® from Bioservo is now classified and approved as a medical device according to the European Medical Device Regulation (EU-MDR), which means that Carbonhand 2.0 can go on sale in Europe.
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. We currently have distributors in Norway, Germany, France and Switzerland and we continue 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."
For more information
Petter Bäckgren, VD, Bioservo Technologies AB
+46 8 21 17 10
petter.backgren@bioservo.com
Niklas Lagström, Global Brand Manager – Life Science, Bioservo Technologies AB
+468 21 17 10
niklas.lagstrom@bioservo.com
About Bioservo Technologies
Bioservo Technologies AB (publ) is a world leading company in wearable muscle strengthening systems for people in need of extra strength and endurance. All our innovative products and systems are designed to keep people strong, healthy, and efficient. The company has a unique global position within soft exoskeleton technology for the hand, both for industrial applications to improve the health for workers and to improve quality of life for people with reduced muscle strength. Bioservo Technologies was founded in 2006 in collaboration between researchers at the Royal Institute of Technology and a doctor at Karolinska University Hospital. Bioservo Technologies is a Swedish public limited company with headquarters in Stockholm.
FNCA Sweden AB is the company’s Certified Adviser on Nasdaq First North.
For more information, please visit www.bioservo.com
