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EMED Announces FDA 510(k) US Market Clearance for the SCIg60 Infusion System
This supplements EMED’s European and Canadian approval and marks the completion of the regulatory process for EU, Canadian and US markets. In addition, the SCIg60® Infusion System is approved for Medicare and Medicaid reimbursement under code E0779.
The SCIg60® Infusion System is a reusable mechanical, non-electronic ambulatory infusion pump intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring) and represents the first mechanical syringe infusion system cleared by the FDA for this indication.
EMED has been working with clinicians to understand and respond to special infusion therapy requirements. As a result, the SCIg60® was designed with unique features that optimize subcutaneous immunoglobulin infusion therapy in a cost-effective manner.
Headquartered in El Dorado Hills, CA, EMED develops, manufactures and markets safety medical products and specialty medical devices.