KORU Medical has received the European Union Medical Devices Regulation (EU MDR) certification for its Freedom60 infusion pump, including an adapter compatible with 50ml prefilled syringes.
The authorisation enables KORU Medical to commercialise the pump throughout the EU.
The infusion pump supports dosing using 50ml prefilled syringes, while the FreedomEDGE infusion system is compatible with 20ml formats.
Together, these devices give clinicians and patients flexibility to manage different dosing regimens while ensuring a simple and consistent user experience.
KORU Medical stated that obtaining EU MDR certification for both the Freedom60 and FreedomEDGE infusion pumps expands access to solutions supporting the increasing use of prefilled syringes in subcutaneous immunoglobulin (SCIg) therapy.
These systems also aim to simplify home infusion experiences for patients.
The adoption of prefilled syringe formats continues to grow within SCIg therapy.
Published research indicates that prefilled presentations can reduce preparation and administration steps compared to vials, minimise medication handling, decrease overall treatment burden, and improve patient confidence and independence with home-based therapy.
KORU Medical president and CEO Linda Tharby said: “EU MDR certification for the Freedom60 Infusion Pump marks an important step in expanding access to simpler, more patient-focused SCIg delivery across Europe.
“As prefilled syringes become more widely adopted, patients are looking for solutions that reduce complexity and fit more easily into their daily routines.
“Our Freedom60 and FreedomEDGE systems are designed to meet that need - helping streamline therapy while maintaining the reliability that clinicians and patients expect.”
KORU Medical’s portfolio includes the Freedom Syringe Infusion System, comprising the Freedom60 and FreedomEDGE syringe infusion drivers, Precision Flow Rate Tubing, and HigH-Flo subcutaneous safety needle sets.
Earlier this year, KORU Medical received 510(k) clearance from the US Food and Drug Administration to use its FreedomEDGE infusion system for administering Rystiggo (rozanolixizumab-noli).
