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KORU Medical Systems Receives the US FDA Clearance for FreedomEDGE System to Deliver Rystiggo in gMG Patients

Shots: The US FDA has granted 510(k) clearance to FreedomEDGE infusion system to subcutaneously administer Rystiggo (rozanolixizumab-noli) in generalized myasthenia gravis (gMG) patients FreedomEDGE Infusion System enables efficient large-volume SC drug delivery, expanding from home use to clinic-based care to deliver life-changing therapies across various care settings The system supports SC drugs with varying viscosity, flow…

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KORU Medical Systems Seeks FDA Clearance for FreedomEDGE System to Deliver Phesgo in HER2+ Breast Cancer Patients

Shots: The US FDA has received the 510(k) premarket notification for FreedomEDGE infusion system to subcutaneously administer Phesgo (Perjeta/Herceptin/hyaluronidase-zzxf) in HER2+ breast cancer The Infusion System enables efficient large-volume SC drug delivery, addressing unmet needs in oncology infusion centers by improving nurse administration experience while supporting faster, more streamlined clinical workflows The system supports SC…

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