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Medical Devices / Submissions and Approvals

EMED Technologies Wins Expanded Indication for Syringe Infusion System

May 24, 2017

EMED Technologies has been granted expanded indications on its FDA-cleared SCIg60 infusion system.

The device administers human plasma-derived immunoglobulin biologics.

The SCIg60 relied upon drug-device compatibility validation for use, which includes subcutaneous infusions of Cuvitru, Gammagard liquid and Hizentra.

The FDA created a new device code “PKP” to classify and regulate infusion systems for immunoglobulins. — Cynthia Jessup

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