Home » EMED Technologies Wins Expanded Indication for Syringe Infusion System
EMED Technologies Wins Expanded Indication for Syringe Infusion System
May 23, 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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