What's Happening?
KORU Medical Systems has announced that its Freedom60 Infusion Pump, along with an adapter for 50 mL prefilled syringes, has received certification under the European Union Medical Devices Regulation (EU MDR 2017/745). This certification allows for the commercialization
of the infusion pump across the European Union. The Freedom60 Infusion Pump is designed to support subcutaneous immunoglobulin (SCIg) therapy, offering a simplified home infusion experience for patients. The certification also covers the FreedomEDGE Infusion System, which is compatible with 20 mL prefilled syringes. This development is part of KORU Medical's strategy to expand access to patient-centric infusion solutions and meet the growing demand for prefilled syringes in SCIg therapy.
Why It's Important?
The EU MDR certification of the Freedom60 Infusion Pump is a significant milestone for KORU Medical Systems, as it expands the company's market reach in Europe. This certification underscores the importance of regulatory compliance in the medical device industry, particularly for companies looking to operate in international markets. The use of prefilled syringes in SCIg therapy is increasing, and KORU Medical's products are positioned to meet this demand, potentially improving patient outcomes and reducing the complexity of home-based treatments. The certification may also enhance the company's competitive edge and drive growth in the European market.
