Repro Med Systems, Inc. Announces FDA Clearance for Delivery of Hizentra? Prefilled Syringes
November 10, 2021 at 04:00 pm EST
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Repro Med Systems, Inc. dba KORU Medical Systems announced 510k clearance for use of the KORU Medical FreedomEdge? infusion pump to deliver Hizentra? [immune globulin subcutaneous (human) 20% liquid] 20 mL prefilled syringes. Hizentra? is the most prescribed subcutaneous Ig product and the first to be available in a prefilled syringe format.
KORU Medical Systems, Inc. designs, manufactures, and markets proprietary portable and advanced medical devices primarily for the subcutaneous drug delivery market. It is focused on home and specialty infusion solutions. The Company's focus is primarily concentrated on its mechanical infusion products, the FREEDOM Infusion Systems, which include the FREEDOM60 Syringe Driver, the FreedomEdge Syringe Driver, HIgH-Flo Subcutaneous Safety Needle Sets, and Precision Flow Rate Tubing. The devices are used for infusions administered at home and in alternate care settings. Its infusion devices work together as a system to deliver life-saving therapies to patients with chronic illnesses, such as primary immunodeficiency diseases (PIDD) and chronic inflammatory demyelinating polyneuropathy (CIDP). The FREEDOM System operates at a lower pressure than an electrical, volumetric pump and maintains a balance between what a patient's subcutaneous tissues can tolerate and what the system delivers.
KORU MEDICAL SYSTEMS, INC. 
