KORU Medical Secures Certification Under EU MDR for Infusion Pump

Why It Matters

The EU MDR clearance unlocks the European market for KORU’s patient‑focused infusion solutions, aligning the company with the rising demand for streamlined home SCIg therapy and potentially expanding its revenue base.

Key Takeaways

• EU MDR cleared Freedom60 pump for 50 ml syringes.
• Enables KORU sales throughout European Union.
• Complements FreedomEDGE, supporting 20 ml and 50 ml formats.
• Prefilled syringes reduce preparation steps and handling.
• Aligns with rising home‑based SCIg therapy demand.

Pulse Analysis

The European Union’s Medical Devices Regulation (MDR) has raised the bar for safety, performance, and clinical evidence across the continent. By securing MDR certification for the Freedom60 infusion pump, KORU Medical demonstrates compliance with these stringent requirements, unlocking the ability to market the device in all 27 EU member states. The certification also validates the pump’s integrated adapter for 50 ml prefilled syringes, a feature that aligns with the regulator’s emphasis on user‑centred design and risk mitigation. This milestone positions KORU ahead of many niche competitors still navigating the MDR approval process.

Subcutaneous immunoglobulin (SCIg) therapy is increasingly delivered at home, and prefilled syringe formats are becoming the preferred choice for clinicians and patients alike. Studies show that prefilled syringes cut preparation time by up to 30 percent, eliminate vial‑reconstitution errors, and improve patient confidence in self‑administration. KORU’s Freedom60, together with the FreedomEDGE system, offers seamless compatibility with both 20 ml and 50 ml cartridges, giving healthcare providers flexibility to tailor dosing regimens without sacrificing simplicity. This adaptability directly addresses the growing demand for streamlined, low‑burden home infusion solutions.

From a commercial perspective, the EU MDR clearance expands KORU’s addressable market by an estimated €150 million in Europe, while the earlier FDA 510(k) for FreedomEDGE opens doors to the lucrative U.S. biologics market, exemplified by the Rystiggo indication. The combined portfolio—including precision tubing and safety needle sets—creates a bundled offering that can be positioned as a complete SCIg delivery ecosystem. As payers increasingly prioritize cost‑effective, patient‑centric therapies, KORU’s certified devices are well‑placed to capture market share and drive sustainable revenue growth.