KORU Medical Systems, Inc., a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, 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.
The 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.
EU 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.
The 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:
• Reduce preparation and administration step vs vials
• Minimize medication handling1
• Decrease overall treatment burden
• Improve patient confidence and independence with 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.”
KORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The Freedom Syringe Infusion System (the “Freedom System”) currently includes the Freedom60 and FreedomEDGE Syringe Infusion Drivers, Precision Flow Rate Tubing and HigH-Flo Subcutaneous Safety Needle Sets.
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