KORU Medical Systems has received the US Food and Drug Administration (FDA) 510(k) clearance to use its FreedomEDGE infusion system for administering Rystiggo (rozanolixizumab-noli).

The therapy is commercialised worldwide by UCB.

The clearance broadens the FreedomEDGE system’s approved use to healthcare professionals, enhancing access and treatment options for patients with generalised myasthenia gravis (gMG).