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