EMED Technologies Corp.'s SCIg60 Infusion System is the first Immune Globulin Subcutaneous (Human) mechanical pump infusion system to be approved by the U.S. Food and Drug Administration.
"We are continually working to improve how our devices can optimize the delivery of life-sustaining and life-enhancing biologics," EMED CEO Paul Lambert said. "Our R&D efforts will continue to chart new technologies with important clinical contributions which will be made available to our pharmaceutical partners."
The FDA clearance will allow for subcutaneous delivery of CUVITRU, an Immune Globulin Infusion (Human) 20 percent, produced by Shire; GAMMAGARD LIQUID, an Immune Globulin Infusion (Human) 10 percent also produced by Shire; and Hizentra, an Immune Globulin Subcutaneous (Human) 20 percent Liquid, produced by CSL Behring.
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