EMED Partners with Global Pharma Leaders in New FDA 510(k) Clearance

EL DORADO HILLS, Calif., May 22, 2017 /PRNewswire/ -- EMED Technologies Corporation is pleased to announce 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. The FDA 510(k) issuance letter can be found at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161906.pdf

Since its initial pioneering efforts in the SCIg market over a decade ago, EMED has been working with Global Pharma leaders to provide innovative infusion platforms for 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.

"We are particularly proud of our joint undertaking 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." – Paul Lambert, CEO of EMED

The SCIg60 system's new FDA clearance relied upon drug-device compatibility validation of the SCIg60 with the indicated human Iggs in support of the expanded indications for use, that now include subcutaneous infusion of the following:

• CUVITRU™ Immune Globulin Infusion (Human) 20% (manufactured by Shire)
• GAMMAGARD LIQUID®, Immune Globulin Infusion (Human) 10% (manufactured by Shire)
• Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring)

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 FDA created a new device code "PKP" to classify and regulate infusion systems for immunoglobulins which can be found at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=2655.

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 continually 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" – Paul Lambert, CEO of EMED

To learn more about EMED visit our website at www.emedtc.com. 

SOURCE EMED Technologies Corporation

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