El Dorado Hills, CA – EMED Technologies announces the SCIg60 Infusion System has been cleared by US FDA with expanded indications for use that now include subcutaneous infusion of the following human plasma-derived immunoglobulin biologics:

• CUVITRU™ Immune Globulin Infusion (Human) 20% (manufactured by Shire)

• GAMMAGARD LIQUID®, Immune Globulin Infusion (Human) 10% (manufactured by Shire)

In 2015, EMED’s SCIg60 was granted FDA 510(k) market clearance for subcutaneous infusion of Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring) establishing it as the first and only syringe infusion system cleared by FDA specifically for infusion of Hizentra.

This most recent expansion of indications has resulted from EMED’s positive interaction with the FDA in the context of increasingly stringent regulations for infusion devices. 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, a testament to EMED’s commitment to the Primary Immunodeficiency community.

“We are particularly proud of our joint development with Shire, the world leader in rare diseases and highly specialized conditions. The opportunity to work along with Shire to optimize Cuvitru and Gammagard delivery protocols has been collaborative and rewarding.

We are working to improve how our devices can optimize the delivery of life-sustaining & life-enhancing biologics. Our R&D efforts will continue to chart new technologies with important clinical contributions which will be made available to our pharmaceutical partners”, said Paul Lambert –CEO of EMED.