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