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KRMD submits 510(k) to use FreedomEDGE system with oncology biologic

KORU Medical Systems, Inc.KRMD recently announced that it has submitted a 510(k) premarket notification for FDA clearance to ...

Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-12 in Narcolepsy Supporting NDA Submission

New Drug Application (NDA) submission on track for January 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome ...
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KORU Medical seeks FDA clearance for infusion system

KORU Medical aims to broaden FreedomEDGE use beyond immunoglobulin indications to reach the oncology infusion centre market.

KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE® System with a Commercialized Oncology Biologic

KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on ...