KORU Medical Systems has received FreedomEDGE infusion system FDA clearance from the US Food and Drug Administration, allowing the device to be used for administering Rystiggo (rozanolixizumab-noli), a therapy commercialised globally by UCB.
The FreedomEDGE infusion system FDA clearance expands the system’s approved use to healthcare professionals in clinical settings, increasing treatment options for patients living with generalised myasthenia gravis. The system is now approved for nine subcutaneous drugs and is used across more than 30 countries.
KORU Medical’s portfolio includes the Freedom60 and FreedomEDGE syringe infusion drivers, precision flow rate tubing, and HigH-Flo subcutaneous safety needle sets. The Freedom Infusion System is used in both home and ambulatory infusion centre environments, following its initial FDA authorisation in 1994.
“With this new FDA clearance, we are proud to further our leadership in the rapidly growing large-volume subcutaneous infusion market, with our ninth subcutaneous drug clearance.
“Expanding from home administration into clinic-based care highlights the versatility of our Freedom Infusion System to deliver life-changing therapies wherever patients are treated. This clearance aligns with our strategy to extend the Freedom platform to more drug therapies, more settings, and more patients.”
In December 2025, KORU Medical submitted a 510(k) premarket notification to the FDA seeking approval for the FreedomEDGE infusion system, which has now been granted.