KORU Medical Systems Receives FDA 510(k) Clearance for the Use of the FREEDOM60® with Two Additional SCIg Drugs
December 21, 2021 at 04:01 pm EST
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Repro Med Systems, Inc. dba KORU Medical Systems announced FDA 510(k) clearance that expands on-label use of the FREEDOM60 Infusion System to two additional subcutaneous Ig (SCIg) medications, Cutaquig®, manufactured by Octapharma, and Xembify®, manufactured by Grifols.
KORU Medical Systems, Inc. designs, manufactures, and markets proprietary portable and advanced medical devices primarily for the subcutaneous drug delivery market. The Company is focused on home and specialty infusion solutions. Its 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 patientâs subcutaneous tissues can tolerate and what the system delivers.
KORU MEDICAL SYSTEMS, INC. 
