MEDRAD nets FDA clearance for FDG infusion system

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MEDRAD has received FDA 510(k) clearance for its new fluorodeoxyglucose (FDG) Intego infusion system for PET/CT imaging procedures. 

The new Intego PET Infusion System is the first infusion system available in the United States to automate the FDG delivery process, the company said.

In automating and controlling the FDG delivery process, the Warrendale, Pa.-based MEDRAD said its Intego system allows healthcare providers to easily administer FDG at any time and enhances the clinician’s ability to deliver FDG with precision and safety. 

The Intego system extracts a patient dose from a multi-dose vial and delivers it directly to the patient, eliminating manual dose preparation and handling, and the corresponding radiation exposure to the technologist, MEDRAD said. With the Intego system’s dose-on-demand capability, the prescribed dose can be delivered when the patient and technologist are ready, allowing technologists to respond to schedule changes, patient delays and add-on patients. 

MEDRAD said it is working with FDG suppliers to provide FDG in multi-dose vials and vial shields compatible with its Intego system and a distribution and marketing agreement with PET radiopharmacy network, PETNet Solutions, a fully owned subsidiary of Siemens Medical Solutions USA.