KORU Medical Secures EU MDR Certification for Freedom60 Infusion Pump
Event summary
- KORU Medical's Freedom60® Infusion Pump with 50 mL prefilled syringe compatibility received EU MDR certification on March 13, 2026.
- The certification enables commercialization across the European Union.
- The FreedomEDGE® Infusion System supports 20 mL prefilled syringe formats.
- Prefilled syringes reduce preparation steps, minimize medication handling, and decrease treatment burden.
The big picture
The EU MDR certification for the Freedom60 Infusion Pump positions KORU Medical to capitalize on the increasing adoption of prefilled syringes in subcutaneous immunoglobulin (SCIg) therapy. This strategic move aligns with broader industry trends toward simplifying home infusion experiences and reducing treatment burdens for patients. The certification underscores KORU Medical's focus on patient-centric solutions and its ability to navigate complex regulatory landscapes.
What we're watching
- Market Expansion
- The pace at which KORU Medical can leverage this certification to expand its market share in Europe.
- Adoption Trends
- Whether the growing use of prefilled syringes in SCIg therapy will drive increased demand for KORU's systems.
- Competitive Dynamics
- How competitors will respond to KORU Medical's enhanced product offerings in the EU market.
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