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Go-Pen

Go-Pen wins CE mark for user-fillable insulin pen

November 11, 2025 By Sean Whooley

Go-Pen insulin pen

Go-Pen announced today on social media that it received CE mark approval for its user-fillable insulin pen. The Denmark-based company said on LinkedIn that, with CE mark now in hand, adding to FDA clearance achieved in May, it now has the foundation needed to bring its insulin pen technology to the U.S. and European market. […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Regulatory/Compliance Tagged With: Go-Pen

Go-Pen ApS wins FDA nod for user-filled insulin pen

May 14, 2025 By Sean Whooley

Go-Pen ApS Go-Pen insulin pen (1)

Go-Pen ApS announced recently that it received FDA 510(k) clearance for its Go-Pen cost-effective, user-filled insulin pen. Copenhagen, Denmark-based Go-Pen ApS says that, despite advances in diabetes technology, approximately one-third of insulin users worldwide (more than 20 million people) rely on traditional vials and syringes due to cost and access limitations. According to a news […]

Filed Under: Diabetes, Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Go-Pen

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