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).
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Rystiggo is a biologic therapy approved for treating adults with gMG, a rare, chronic autoimmune disorder that disrupts nerve to muscle communication.
It is administered via weekly infusions of 3ml to 6ml over 15 to 30 minutes for six weeks, with subsequent cycles determined by clinical assessment.
The infusion system is designed to administer large-volume subcutaneous medications, accommodating a range of viscosities, flow rates, and drug volumes spanning from 5ml to more than 50ml.
It is approved for nine subcutaneous drugs across more than 30 countries.
The company’s product portfolio currently includes the Freedom60 and FreedomEDGE syringe infusion drivers, precision flow rate tubing, and HigH-Flo subcutaneous safety needle sets.
KORU Medical president and CEO Linda Tharby said: “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.”
The system received initial FDA authorisation in 1994 and is used in both home and ambulatory infusion centre settings.
In December 2025, KORU Medical submitted a 510(k) premarket notification to the FDA seeking approval for its FreedomEDGE infusion system.
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