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.

Go-Pen labels its system as a user-friendly, cost-effective insulin pen designed for accessibility, sustainability and reliability. The company said it engineered the device for reuse for up to three years. It features a 1.3 mL disposable reservoir that users can fill directly from a standard insulin vial. This enables broad access and reduced waste, Go-Pen says.

The company says 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.