KORU Medical Systems has announced that its Freedom60 Infusion Pump, including the adapter designed for use with 50 mL prefilled syringes, has received certification under the European Union Medical Devices Regulation (EU MDR 2017/745). The certification allows the company to commercialise the device across the European Union.

The Freedom60 Infusion Pump is developed to support treatment using 50 mL prefilled syringes, while the FreedomEDGE Infusion System offers compatibility with 20 mL prefilled syringe formats. Together, these systems provide flexibility for clinicians and patients across different dosing regimens while maintaining a consistent and user-friendly experience.

Certification under the EU MDR for both the Freedom60 and FreedomEDGE infusion pumps is expected to broaden patient access to infusion systems designed to support the increasing use of prefilled syringes in subcutaneous immunoglobulin (SCIg) therapy. The systems are also intended to simplify home infusion treatment for patients.

The growing availability of prefilled syringe formats has been considered an important development in SCIg therapy. Studies indicate that prefilled presentations can reduce the number of preparation and administration steps compared with traditional vial-based systems. They can also limit medication handling, reduce treatment burden and help improve patient confidence and independence when managing therapy at home.

According to the company, the certification marks a significant step in expanding access to simpler and more patient-focused SCIg delivery options across Europe. As the use of prefilled syringes continues to increase, there is rising demand for treatment solutions that reduce complexity and integrate more easily into patients’ daily routines.

KORU Medical Systems focuses on developing and commercialising large-volume subcutaneous infusion technologies aimed at improving the quality of life for patients requiring chronic therapies. Its Freedom Syringe Infusion System includes the Freedom60 and FreedomEDGE syringe infusion drivers along with precision flow rate tubing and specialized subcutaneous safety needle sets designed for efficient and reliable drug delivery.