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

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 release, more than 3 million insulin users in the U.S. alone depend on syringes for daily insulin administration.

The company said its Go-Pen addresses this gap by allowing users to refill the device from standard insulin vials. This reduces the cost per dose compared to traditional disposable pens. Its design enables individuals in low-resource settings to manage their diabetes with improved ease and precision.

Go-Pen ApS says it put the device through rigorous physical, chemical and human factors studies to ensure safety and effectiveness in diverse environments. The company reports positive user feedback, indicating the device’s global potential.

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