Koru Medical Systems (Nasdaq:KRMD) announced today that it submitted its Freedom60 infusion system for FDA 510(k) clearance.
The submission covers the use of the Freedom60 infusion system with the Hizentra 50 mL prefilled syringe.
In January, Koru inked a development agreement with a manufacturer of subcutaneous immunoglobulin therapy (SCIg). The deal sought to garner regulatory clearance for Freedom Infusion System with an SCIg prefilled syringe. Mahwah, New Jersey-based Koru received FDA approval for the 50 mL Hizentra prefilled syringe in April 2023.
According to the company, Hizentra is the most prescribed subcutaneous immunoglobulin. It’s also the first to be made available in prefilled syringes.
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