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KORU Medical Seeks FDA Clearance for FreedomEDGE Infusion System in Q4 2025/Q1 2026
ByAinvest
Tuesday, Nov 18, 2025 6:42 am ET1min read
KORU Medical Systems plans to submit a 510(k) application to the FDA for its FreedomEDGE Syringe Infusion System in Q4 2025/Q1 2026, seeking clearance for use with a commercialized oncology drug. The system enables, simplifies, and enhances the delivery of large-volume subcutaneous drugs, supporting volumes from 5 mL to 50 mL+. The company will present data from a multicenter study at the ESID/EHA/SIOPE Focused Symposium in Vienna, Austria.
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