KORU Medical’s FreedomEDGE System Cleared by FDA for Rystiggo Administration

KORU Medical Systems has received FDA 510(k) clearance for its FreedomEDGE infusion system to administer Rystiggo (rozanolixizumab-noli), commercialized by UCB, for adults with generalised myasthenia gravis (gMG).

The clearance expands the system’s use to healthcare professionals, enhancing treatment access beyond home settings. Rystiggo is given via weekly subcutaneous infusions of 3–6 ml over 15–30 minutes for six weeks, with subsequent cycles guided by clinical assessment.

The FreedomEDGE system can deliver large-volume subcutaneous medications ranging from 5 ml to over 50 ml, accommodating various viscosities and flow rates. It is approved for nine subcutaneous drugs across more than 30 countries.

KORU’s portfolio includes the Freedom60 and FreedomEDGE syringe drivers, precision flow tubing, and HigH-Flo safety needle sets. 

31-01-2026