EMED Announces FDA 510(k) US Market Clearance for the SCIg60® Infusion System
May 20, 2015
El Dorado Hills, CA - EMED Technologies Corporation is pleased to announce that on May 8,
2015, the SCIg60® Infusion System was granted FDA clearance for interstate commerce within the United
States.
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 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.
About EMED
EMED Technologies is an industry leader in the design, manufacture, and distribution of cutting-edge medical devices. For two decades, EMED Technologies has worked with clinicians, inventors, and medical companies to develop innovative medical products. Today, we are proud that both patients and clinicians can benefit from the fruits of our labor because we offer a wide variety of products and services that improve therapies and enhance clinical benefits. Also, with our dynamic team of professionals, EMED continues to work with clinicians to understand their requirements and improve upon available technologies, and we are confident that these endeavors will benefit generations to come! In addition to novel technology, EMED is proud to offer licensing agreements for patented and proprietary technologies.
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