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KORU Medical's FREEDOM60® Infusion System with Hizentra® 50 ML Syringes Receives FDA 510(k) Clearance

Wednesday, November 08, 2023

KORU Medical Systems, a prominent player in the medical technology industry, has received FDA clearance for its FREEDOM60® Infusion System in conjunction with Hizentra® 50 mL prefilled syringes (PFS). This landmark achievement establishes the FREEDOM60® Infusion System as the first and only FDA-approved infusion system for use with prefilled syringes, underlining KORU Medical's unwavering commitment to enhancing the patient experience, particularly for individuals self-administering subcutaneous immunoglobulin (SCIg) therapy at home.

Prefilled syringes offer a user-friendly solution and enable the administration of higher doses of immunoglobulin, offering significant benefits to patients diagnosed with Primary Immunodeficiency Disease (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). KORU Medical is now extending these advantages to Hizentra® patients through its FREEDOM™ Infusion System portfolio, which includes the FREEDOM60® Infusion System with 50 mL PFS and the FreedomEdge® with 20 mL PFS. This advancement has the potential to expand the use of SCIg in home settings, providing a more convenient option for patients.

The FREEDOM™ Infusion System is the first and only system approved for use with prefilled syringes, which is particularly beneficial for patients who require doses of 50 mL or more. When patients use prefilled syringes with the FREEDOM™ Infusion System, it can reduce drug preparation tasks by up to 80% compared to using vials.


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