MEDRAD Receives FDA 510(k) Clearance for FDG Infusion System

Wednesday, June 18, 2008 General News
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WARRENDALE, Pa., June 17 MEDRAD, INC., announced todaythat 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 firstinfusion system available in the United States to automate the FDG deliveryprocess.

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In automating and controlling the FDG delivery process, the Intego Systemenables the healthcare provider to easily administer FDG at any timethroughout the day and enhances the clinician's ability to deliver FDG withprecision, flexibility, and safety.

The Intego System automatically extracts a patient dose from a multi-dosevial and delivers it directly to the patient, virtually eliminating manualdose preparation and handling, and the corresponding radiation exposure to thetechnologist. With the Intego System's dose-on-demand capability, theprescribed 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-timedose availability information, an integrated ionization chamber, and anoptional weight-based dose calculation, allow the healthcare provider to moreprecisely customize each patient's dose. Safety features include a tungstenmulti-dose vial shield, a fully lead-lined mobile cart, and an automatedsaline flush to remove residual FDG from the line after each infusion.

"MEDRAD has a strong heritage of developing innovative products to improvefluid delivery for Cardiovascular (CV), Magnetic Resonance (MR) and ComputedTomography (CT) imaging procedures. With our new Intego system that fullyautomates FDG delivery, we can once again improve how molecular imaging isdone," said Cliff Kress, senior vice president, CT Business Unit.

MEDRAD is working with FDG suppliers to provide FDG in multi-dose vialsand vial shields compatible with the Intego System and recently announced adistribution and co-marketing agreement with the largest PET radiopharmacynetwork, PETNET Solutions, a fully owned subsidiary of Siemens MedicalSolutions USA, Inc.


MEDRAD, INC., is a worldwide leading provider of medical devices andservices that enable and enhance imaging procedures of the human body. Used indiagnostic imaging, MEDRAD's product offerings include a comprehensive line ofvascular injection systems, magnetic resonance (MR) surface coils and patientcare products, and equipment services. Total 2007 revenues were $525 million.MEDRAD is a 2003 recipient of the Malcolm Baldrige National Quality Award, thetop honor a U.S. company can receive for quality and business excellence. Thecompany's world headquarters is near Pittsburgh, Pennsylvania, in the UnitedStates. MEDRAD is an affiliate of Bayer AG.

The Bayer Group is a global enterprise with core competencies in thefields of healthcare, nutrition and high-tech materials. Bayer HealthCare, asubsidiary of Bayer AG, is one of the world's leading, innovative companies inthe healthcare and medical products industry and is based in Leverkusen,Germany. The company combines the global activities of the Animal Health,Consumer Care, Diabetes Care and Pharmaceuticals divisions. Thepharmaceuticals business operates under the name Bayer Schering Pharma AG.Bayer HealthCare's aim is to discover and manufacture products that willimprove human and animal health worldwide. Find more information at

Cautionary statement regarding forward-looking statement.

Certain statements in this press release that are neither reportedfinancial results nor other historical information are forward-lookingstatements, including but not limited to, statements that are predictions

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