KORU Medical Seeks FDA Clearance to Expand FreedomEDGE into Oncology Infusions

KORU Medical has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its FreedomEDGE infusion system, aiming to support subcutaneous delivery of PHESGO, a co-formulated therapy for HER2-positive breast cancer. The filing marks a strategic move to extend the system’s use beyond immunoglobulin therapies and into the oncology infusion centre setting.

FreedomEDGE is designed to enable consistent, controlled delivery of large-volume subcutaneous drugs while supporting efficient and streamlined clinical workflows. According to the company, the system can accommodate a wide range of flow rates, viscosities, and drug volumes, helping to meet the complex requirements of biologic therapies.

KORU expects to commercialise the system for oncology use following FDA clearance. Its Freedom Infusion System has more than 15 years of market experience, supporting over 45,000 patients and more than two million infusions annually across 30 countries. In July 2024, FreedomEDGE also received regulatory clearance in Japan, reinforcing KORU’s global expansion strategy.

03-01-2026