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KRMD Submits 510(k) to Use FreedomEDGE System With Oncology Biologic
ZACKS· 2026-01-01 00:31
Key Takeaways KRMD submitted a 510(k) seeking FDA clearance to use FreedomEDGE for subcutaneous delivery of PHESGO.KRMD views the filing as a key step in shifting oncology care from IV infusions to subcutaneous delivery.FreedomEDGE can improve efficiency for infusion centers by reducing treatment time and easing nurse workload.KORU Medical Systems, Inc.(KRMD) recently announced that it has submitted a 510(k) premarket notification for FDA clearance to use its FreedomEDGE infusion system to deliver PHESGO, a ...