MEDRAD Receives FDA 510(k) Clearance For Wireless MR Infusion System

Main Category: MRI / PET / Ultrasound
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 Aug 2008 - 1:00 PDT

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MEDRAD, INC., announced that the wireless version of its Continuum MR Infusion System has received U.S. Food and Drug Administration (FDA) 510(k) clearance.

The new Continuum Wireless MR Infusion System enables the clinician to control a patient's medication infusion during a magnetic resonance (MR) procedure from both inside and outside the scan room. When changes are needed, including flow rate, bolus, or to start or stop the infusion altogether, clinicians can control these parameters without interrupting the MRI scan with a new wireless remote display featuring a color touch screen. This option will increase workflow efficiencies and throughput while enhancing clinician confidence by enabling easy selection from up to nine IV stands, minimizing scan interruptions due to infusion changes and displaying all infusion parameters.

"The Continuum Wireless is designed to produce efficiency and boost throughput in MRI, but it also builds confidence in the patient care staff that control of a patient's medication is always nearby, especially when implemented for applications like pediatric sedation," said Joe Havrilla, senior vice president, MEDRAD MR Business Unit.

Continuum Wireless joins the Veris(R) MR Monitor as the second product to utilize MEDRAD's Certo(TM) MR Wireless Network.

The original Continuum MR Infusion System was introduced in 2002 as the first infusion system designed for the harsh electro-magnetic environment in MR. MEDRAD has designed an upgrade path to wireless for current Continuum users.

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.

MEDRAD, INC.
http://www.medrad.com