KORU Medical Systems Submits 510(k) Application for FreedomEDGE Oncology Infusion System
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KORU Medical Systems Inc. has submitted a 510(k) application to the FDA for its FreedomEDGE® infusion system, aimed at subcutaneous administration of PHESGO® for HER2+ breast cancer treatment. This submission expands the system's use into the oncology infusion market, with anticipated market entry following FDA clearance.
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