MAHWAH, N.J. — KORU Medical Systems, Inc. (NASDAQ: KRMD) announced that its Freedom60 Infusion Pump, including an adapter designed for use with 50 mL prefilled syringes, has received certification under the European Union Medical Devices Regulation (EU MDR 2017/745), allowing the device to be commercialized across the European Union.
The Freedom60 Infusion Pump is designed to support dosing with 50 mL prefilled syringes, while the company’s FreedomEDGE Infusion System offers compatibility with 20 mL prefilled syringe formats. Together, the systems are intended to provide clinicians and patients flexibility across different dosing regimens while maintaining a consistent and easy-to-use infusion platform.
KORU said EU MDR certification for both the Freedom60 and FreedomEDGE infusion pumps expands access to technology designed to support the growing use of prefilled syringes in subcutaneous immunoglobulin (SCIg) therapy and simplify the home infusion process for patients.
The company noted that prefilled syringe formats have increasingly been adopted in SCIg therapy and can offer several potential advantages over traditional vial-based administration. Studies have indicated that prefilled presentations may reduce preparation and administration steps, minimize medication handling, lower overall treatment burden and improve patient confidence and independence during home therapy.
“EU MDR certification for the Freedom60 Infusion Pump marks an important step in expanding access to simpler, more patient-focused SCIg delivery across Europe,” said Linda Tharby, President and Chief Executive Officer of KORU Medical Systems. “As prefilled syringes become more widely adopted, patients are looking for solutions that reduce complexity and fit more easily into their daily routines. Our Freedom60 and FreedomEDGE systems are designed to meet that need – helping streamline therapy while maintaining the reliability that clinicians and patients expect.” (Source: IANS)
