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.
Copenhagen, Denmark – May 7, 2025. GO-Pen ApS, a Danish medical device company committed to enhancing global health equity, has achieved an important milestone in its work to improve diabetes care access. The company announced today that its cost-effective user-filled insulin pen, GO-PEN®, has received FDA 510(k) clearance, enabling market entry in the United States and internationally.
"Our mission has always been to democratise access to essential diabetes care," says Ole Kjerkegaard Nielsen, CEO and Co-founder of GO-Pen ApS. "Receiving FDA clearance is a significant step toward realising our vision of making high-quality insulin delivery accessible to all, regardless of geographic or economic barriers."
Despite advances in diabetes technology, approximately one-third of insulin users worldwide—over 20 million people—continue to rely on traditional vials and syringes due to cost and access limitations. In the United States alone, studies indicate that more than 3 million insulin users, many uninsured or underinsured, remain dependent on syringes for their daily insulin administration.
GO-PEN® addresses this gap by allowing users to refill the device from standard insulin vials, reducing the cost per dose compared to traditional disposable pens. This design enables individuals in low-resource settings to manage their diabetes with improved ease and precision.
Medical experts and patients review Go-Pen®
"GO-Pen is the most innovative concept I have ever seen towards the needs of patients who take insulin using syringes," says Anne Peters, Professor at Keck School of Medicine, a diabetes specialist who directs diabetes centres in both Beverly Hills and underserved East Los Angeles.
The device has undergone rigorous physical, chemical and human factors studies to ensure its effectiveness and safety in diverse environments. User feedback has been positive, indicating GO-PEN®'s potential to improve diabetes management globally.
"I have just tried GO-PEN®, and I was very comfortable using it. It is going to be a very exciting product, and it will help many people with diabetes," says Nupur Lalvani, founder of Blue Circle Foundation in India, who has been living with type 1 diabetes for over 25 years and runs a non-profit organisation focused on diabetes awareness and advocacy.
Looking ahead: Commercialisation plans
With FDA clearance secured, GO-Pen ApS is now advancing its commercial strategy. The company is converting existing letters of intent into formal launch contracts with partners to ensure broad access to GO-PEN®.
To support manufacturing scale-up and meet demand, GO-Pen ApS is planning to raise €5 million in equity capital following the summer break.
For more information about GO-PEN® and its approach to improving insulin delivery accessibility, please visit www.go-pen.com
Media Contact:
Ole Kjerkegaard Nielsen
CEO and Co-founder, GO-Pen ApS
Email: ole@go-pen.com
Phone: +45 53 77 24 74
