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KORU Medical Systems Announces EU MDR Certification for the Freedom60® Infusion Pump With Prefilled Syringe Compatibility
MAHWAH, N.J.--(BUSINESS WIRE)-- KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on
About this update from Koru Medical Systems, Inc.
[{"type":"text","content":" MAHWAH, N.J.--(BUSINESS WIRE)--\nKORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced that its Freedom60® Infusion Pump, including adapter for use with 50 mL prefilled syringes, has achieved certification under the European Union Medical Devices Regulation (EU MDR 2017/745), enabling commercialization across the European Union.\n\n\nThe Freedom60 Infusion Pump is designed to support dosing with 50 ml prefilled syringes, while the FreedomEDGE® Infusion System provides a compatible option for 20 mL prefilled syringe formats. Together, these systems offer clinicians and patients flexibility across dosing regimens while maintaining a consistent, intuitive user experience.\n\n\nEU MDR certification of both the Freedom60 and FreedomEDGE Infusion Pumps expands access to a system designed to support the growing use of prefilled syringes in subcutaneous immunoglobulin (SCIg) therapy and simplify the home infusion experience for patients.\n\n\nThe increasing availability of prefilled syringe formats represents an important step forward in the evolution of SCIg therapy. Published studies have shown that prefilled presentations can:\n\n\n\nReduce preparation and administration step vs vials1\n\n\n\nMinimize medication handling1\n\n\n\nDecrease overall treatment burden2\n\n\n\nImprove patient confidence and independence with home therapy3\n\n\n\n“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.”\n\n\nAbout KORU Medical Systems\n\n\nKORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients arou...