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MEDRAD Receives FDA 510(k) Clearance for FDG Infusion System
Date:6/17/2008

WARRENDALE, Pa., June 17 /PRNewswire/ -- MEDRAD, INC., announced today that it received FDA 510(k) clearance for a new Fluorodeoxyglucose (FDG) Infusion System for Positron Emission Tomography/Computed Tomography (PET/CT) imaging procedures. The new Intego(TM) PET Infusion System is the first infusion system available in the United States to automate the FDG delivery process.

(Logo: http://www.newscom.com/cgi-bin/prnh/20040309/MEDRADLOGO )

In automating and controlling the FDG delivery process, the Intego System enables the healthcare provider to easily administer FDG at any time throughout the day and enhances the clinician's ability to deliver FDG with precision, flexibility, and safety.

The Intego System automatically extracts a patient dose from a multi-dose vial and delivers it directly to the patient, virtually eliminating manual dose preparation and handling, and the corresponding radiation exposure to the technologist. With the Intego System's dose-on-demand capability, the prescribed dose can be delivered when the patient and technologist are ready, enabling technologists to easily and efficiently respond to schedule changes, patient delays, and add-on patients. Innovative features, including real-time dose availability information, an integrated ionization chamber, and an optional weight-based dose calculation, allow the healthcare provider to more precisely customize each patient's dose. Safety features include a tungsten multi-dose vial shield, a fully lead-lined mobile cart, and an automated saline flush to remove residual FDG from the line after each infusion.

"MEDRAD has a strong heritage of developing innovative products to improve fluid delivery for Cardiovascular (CV), Magnetic Resonance (MR) and Computed Tomography (CT) imaging procedures. With our new Intego system that fully automates FDG delivery, we can once again improve how
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SOURCE MEDRAD, INC.
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