KORU Medical Systems Submits 510(k) Application for FreedomEDGE Oncology Infusion System

Reuters

Dec 31, 2025

KORU Medical Systems Submits 510(k) Application for FreedomEDGE Oncology Infusion System

KORU Medical Systems Inc. has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for its FreedomEDGE® infusion system to be used for subcutaneous administration of PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a therapy for HER2+ breast cancer. This submission marks a significant step in expanding the use of the FreedomEDGE® system beyond immunoglobulin indications and into the oncology infusion center market. KORU Medical anticipates market entry upon FDA 510(k) clearance.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. KORU Medical Systems Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251230163792) on December 30, 2025, and is solely responsible for the information contained therein.

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