EMED Partners with Global Pharma Leaders in New FDA 510(k) Clearance
EMED Technologies today announced that the SCIg60® Infusion System has been granted expanded indications as the only Immune Globulin Subcutaneous (Human) mechanical pump infusion system cleared by the U.S. FDA.
Since its initial pioneering efforts in the SCIg market over a decade ago, EMED has worked with global pharmaceutical leaders to provide innovative infusion platforms for the administration of human plasma-derived immunoglobulin biologics. In this most recent FDA clearance, Shire was directly involved in the selection of infusion criteria required by Shire's biologics and endorsed EMED's 510(k) premarket clearance submission accordingly.
The new FDA 510(k) clearance establishes the SCIg60® system as the first and only syringe infusion system cleared by FDA specifically for subcutaneous infusion of immunoglobulin solutions. Expanded indications now include CUVITRU™ Immune Globulin Infusion (Human) 20% (Shire), GAMMAGARD LIQUID® Immune Globulin Infusion (Human) 10% (Shire), and Hizentra® Immune Globulin Subcutaneous (Human), 20% Liquid (CSL Behring).
The clearance reinforces EMED's role as a trusted technology partner to the world's leading immunoglobulin manufacturers and underscores the Company's commitment to advancing therapy access for patients with Primary Immunodeficiency and other conditions requiring regular infusion.
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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Original release
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