Go-Pen receives CE Mark (Class IIb) for its user-fillable insulin pen – ready for global rollout
Danish medtech company Go-Pen ApS has received CE Mark approval in Class IIb under the EU Medical Device Regulation (MDR) for its user-fillable insulin pen, which is now approved for use with a range of commercial insulin formulations.
GO-PEN® receives FDA 510(k) clearance for innovative user-filled insulin pen
Danish medical device company GO-Pen ApS receives FDA clearance for its cost-effective user-filled insulin pen, addressing the need for affordable insulin delivery solutions. This technology aims to improve diabetes care for over 20 million insulin users still dependent on vials and syringes globally, with market entry preparations now underway in the United States and beyond.
Why does GO-Pen exist?
GO-Pen’s CEO and co-founder Ole Kjerkegaard Nielsen, featured in Dutch TV-programme De Barometer, explains why he started the company and how GO-Pen will improve diabetes care for millions of people.