The FreedomEDGE system is developed to provide consistent, controlled large-volume subcutaneous delivery and support streamlined clinical workflows. Credit: Peakstock/Shutterstock.com.

KORU Medical has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) seeking approval for its FreedomEDGE infusion system.

The submission is intended for using the FreedomEDGE system to subcutaneously deliver pertuzumab/trastuzumab/hyaluronidase-zzxf (PHESGO), a co-formulated therapy for human epidermal growth factor receptor (HER)2-positive breast cancer.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

The company aims to broaden the application of the system beyond its current immunoglobulin indications to reach the oncology infusion centre market.

FreedomEDGE is developed to provide consistent and controlled large-volume subcutaneous delivery, and to support streamlined clinical workflows.

The company expects to enter the market following FDA 510(k) clearance. The Freedom Infusion System has over 15 years of market presence, with more than 45,000 patients and over two million infusions yearly.

According to KORU Medical, the system supports various requirements for flow rate, viscosity, and delivered drug volume, with a 97% adherence rate and eight on-label subcutaneous drugs across more than 30 countries.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

KORU Medical president and CEO Linda Tharby said: “The submission of our 510(k) for clearance of the FreedomEDGE with a subcutaneous oncology biologic is a pivotal milestone for KORU. It sets the foundation for future growth and underscores our strategy to expand KORU’s leadership into the growing drug delivery device market for oncology therapies.

“This regulatory filing and expected clearance represents an exciting opportunity to enter a new point of care where we believe our technology can address a meaningful unmet need by improving the administration experience for nurses while supporting greater efficiency in oncology infusion centres.”

In July 2024, KORU Medical secured regulatory clearance in Japan for its FreedomEDGE infusion system.

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
Awarded for Innovation in Remote Hearing Diagnostics , hearX’s Self Test Kit (STK) delivers clinically validated audiometry via smart devices, enabling remote, scalable hearing assessments in homes, clinics and retail. Learn how hearX is redefining hearing care delivery and reducing costs for providers globally.

Discover the Impact