EMED Announces FDA 510(k) US Market Clearance for the SCIg60® Infusion System
EMED Technologies today announced that its SCIg60® Infusion System has been granted FDA 510(k) clearance for the U.S. market, establishing it as the first and only syringe-based mechanical pump cleared by the FDA for subcutaneous immunoglobulin (SCIg) infusion.
The initial clearance covers the subcutaneous infusion of Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, manufactured by CSL Behring. With this clearance, the SCIg60® becomes a uniquely positioned solution for the growing population of patients who require regular SCIg therapy.
The SCIg60® is designed to deliver consistent, patient-friendly infusions in both clinical and home settings, and reflects EMED's long-standing commitment to advancing the safety, simplicity, and accessibility of subcutaneous infusion therapy.
For more information about the SCIg60® and EMED's full portfolio, visit emedtc.com.
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. With our dynamic team of professionals, EMED continues to work with clinicians to understand their requirements and improve upon available technologies. In addition to novel technology, EMED is proud to offer licensing agreements for patented and proprietary technologies.
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