Healthcare Industry News:  computed tomography 

Devices Radiology FDA

 News Release - June 17, 2008

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

WARRENDALE, Pa., June 17 (HSMN NewsFeed) -- 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.

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 molecular imaging is done," said Cliff Kress, senior vice president, CT Business Unit.

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

About MEDRAD

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

The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the 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. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at http://www.bayerhealthcare.com.

Cautionary statement regarding forward-looking statement.

Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and MEDRAD's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. MEDRAD, INC., undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.


Source: MEDRAD

Issuer of this News Release is solely responsible for its content.
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