Koru Medical Systems Gets Expanded Clearance for Its Infusion System

January 4, 2022

New York-based Koru Medical Systems has received the FDA’s 510(k) clearance for expanded use of its Freedom60 infusion system to include two additional antibody treatments.

The system was previously cleared for use with CSL Behring’s Hizentra prefilled syringes (immune globulin subcutaneous [human], 20 percent liquid).

The Freedom60 system is now also cleared for delivery of Octapharma’s Cutaquig (immune globulin subcutaneous [human]-hipp, 16.5 percent solution) and Grifols’ Xembify (immune globulin subcutaneous human-klhw).

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