FDA Grants First-of-Its-Kind Clearance to KORU Medical Systems for FREEDOM60® Infusion System with Hizentra® 50 ML Prefilled Syringes

KORU Medical Systems, a prominent player in medical technology, has announced the FDA clearance for its FREEDOM60® Infusion System paired with Hizentra® 50 mL prefilled syringes (PFS). This milestone signifies the first and exclusive FDA approval for an infusion system designed specifically for prefilled syringes, reflecting KORU Medical's steadfast commitment to improving the self-administration experience for patients undergoing subcutaneous immunoglobulin (SCIg) therapy at home.

The integration of prefilled syringes into the FREEDOM™ Infusion System portfolio, encompassing the FREEDOM60® Infusion System with 50 mL PFS and the FreedomEdge® with 20 mL PFS, underscores KORU Medical's dedication to elevating the quality of life for patients. This achievement not only simplifies drug administration but also unlocks significant benefits, particularly for patients requiring higher doses of immunoglobulin, such as those diagnosed with primary immunodeficiency disorders (PIDD) and chronic inflammatory demyelinating polyneuropathy (CIDP).

Prefilled syringes have demonstrated a substantial improvement in user convenience for all patients, offering an efficient solution for immunoglobulin administration. This FDA clearance opens up new avenues for expanding the use of SCIg in home settings. KORU Medical's FREEDOM™ Infusion System, a pioneering solution approved for prefilled syringe use, facilitates an impressive up to 80% reduction in drug preparation tasks compared to conventional vial usage, showcasing a significant advancement in patient-friendly infusion technology.


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