The approval of the Freedom60 Infusion System for use with HIZENTRA® 50 mL prefilled syringes in March 2026 represents a significant advancement in subcutaneous therapy delivery across the UK and EU.
Using the Freedom60 Infusion System, with the Prefilled Syringe Adapter and HIZENTRA prefilled syringes reduces the number of infusions steps and eliminates the drug transfer process for HIZENTRA infusions. This makes the process even simpler for patients, easier for them to manage themselves at home and safer overall. The Freedom60 Prefilled Syringe Adapter is maintenance-free, allowing for reliability and ease of use with patients able to easily attach and remove the syringe adapter in one simple step. For patients, clinicians, and healthcare systems alike, this recent approval is a meaningful step toward more efficient, patient-centred care.
A milestone in SCIg therapy delivery
The landscape of subcutaneous immunoglobulin (SCIg) therapy continues to evolve, with a strong focus on improving patient experience, simplifying administration, and supporting home-based care. A major milestone in this evolution came in March 2026, when Koru Medical Systems announced that the Freedom60® Infusion System, including compatibility with 50 mL prefilled syringes, achieved certification under the European Union Medical Devices Regulation (EU MDR 2017/745).
The EU MDR certification marks a significant step forward in enabling wider access to modern, patient-centric infusion systems. This approval enables the system to be commercialised and used across the UK and European Union, supporting therapies such as HIZENTRA® (human immunoglobulin) delivered via prefilled syringes.
“EU MDR certification for the Freedom60 Infusion Pump marks an important step in expanding access to simpler, more patient-focused SCIg delivery across Europe,” said Linda Tharby, President and Chief Executive Officer of Koru Medical Systems, in a recent press release about the announcement.
“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.”
This latest regulatory milestone ensures that patients and clinicians across Europe can benefit from a fully compatible, validated delivery system.
Benefits for patients
The combination of the Freedom60 system with HIZENTRA® prefilled syringes offers several meaningful benefits for patients, particularly those managing long-term conditions who require frequent infusions:
- Reduced preparation time – Prefilled syringes eliminate many manual steps required with vial-based systems
- Simplified administration – Fewer handling steps make the process easier and less intimidating
- Greater independence – Patients can confidently self-administer treatment at home
- Improved quality of life – Easier treatment integrates more naturally into daily routines
Benefits for clinicians and healthcare providers
For clinicians, the approval brings both practical and clinical advantages:
- Standardisation of therapy delivery with prefilled formats
- Reduced training complexity for patients and caregivers
- Improved adherence due to easier administration
- Lower risk of preparation errors
- Enhanced confidence in home therapy protocols
Ultimately, this supports more efficient care pathways and better patient outcomes.
What is the Freedom60® Syringe Infusion System?
The Freedom60® Syringe Infusion System is a lightweight, portable syringe infusion system/pump designed specifically for subcutaneous drug delivery. It forms part of the wider Freedom Infusion System developed by KORU Medical. Ideal for large doses or recurring infusions at home. While it can accommodate all dosing ranges, it is recommended for patients with a dosage of 35ml or greater.
This easy-to-use device allows patients who require regular infusions at home the convenience of administering these in the comfort of their own home on their own time. Allowing for infusions in three easy steps, it provides constant pressure for safe delivery for both patients and clinicians.
The system has been used globally for decades and is trusted for delivering therapies such as immunoglobulins in both clinical and home environments. Compatible with other Koru products supplied by Amdel Medical, including precision flow rate tubing and needle set, the Koru products work together perfectly in their own ecosystem. With the addition of 50 mL prefilled syringe compatibility, the Freedom60 system is now even more aligned with modern drug delivery formats.
Available in the UK and Ireland exclusively through Amdel Medical who are proud to be the UK’s premium supplier or Koru products. Like Koru we believe that individuals needing medical treatment should have the freedom to fully enjoy life.
Amdel Medical: Suppliers of the Freedom60
As the UK supplier of Koru Medical products, Amdel Medical plays a critical role in ensuring access to the Freedom60 system for healthcare providers and patients across the country.
Through its partnership with Koru Medical, Amdel Medical can supply the Freedom60® Syringe Infusion System to healthcare providers throughout the UK and provide expert product guidance, training and ongoing support. As a trusted supplier for many within the healthcare community, we are renowned for supplying the most innovative products on the market, centred around enhancing both patient care and clinical efficiency.
For more information on how we can assist you or if you are interested in the Freedom60 system, get in touch with our friendly team today.