BEAVERTON, Ore.--(BUSINESS WIRE)--June 23, 2004--Planar Systems,
Inc. (Nasdaq:PLNR), a worldwide leader in flat-panel display systems,
has received FDA 510(k) approval to market the flat-panel Dome(R)C5i
system for displaying and viewing mammograms.
Until now, the only FDA approved equipment for all soft copy
mammography reviews employed cathode-ray tube (CRT) displays, limiting
choice and excluding radiologists from flat-panel technology's image
quality, ergonomic and quality-assurance benefits.
FDA approval follows clinical evaluations conducted at the
prestigious Elizabeth Wende Breast Clinic in Rochester, N.Y. Final
evaluation results were published by Ovation Research Group and
include specific performance data on display of mass features, calcium
features and architectural distortion features. The study was
performed in conjunction with evaluations of Fischer Imaging's
SenoScan(R) Full-Field Digital Mammography System. Evaluations
demonstrated that Planar's Dome C5i is equivalent to and, in many
respects, better than 5MP CRT displays of full-field digital
mammograms over a wide range of mammography cases.
"We are pleased to have partnered with Planar and Elizabeth Wende
Breast Clinic in the clinical trials of the C5i flat panel displays,"
said Janine Broda, vice president of marketing of Fischer Imaging, the
system partner in the approval process. "Fischer is committed to
providing the best possible technology solutions in digital
mammography, which includes a broad range of options for managing our
customers' digital mammography image solutions. This announcement
represents an advancement in imaging displays that further supports
our efforts for the early diagnosis of breast cancer."
"With FDA approval of the Dome C5i for use in mammography --
perhaps the most demanding clinical application for display technology
-- Planar continues to affirm its market leadership and drive the
industry toward adoption of flat-panel display technology," said Steve
Flieder, vice president and general manager of Planar's medical
business. "We are delighted with the overwhelmingly positive response
we received during clinical trials for the Dome C5i and see this as a
win for radiologists and their patients, as well as picture archiving
and communications systems (PACS) administrators, IT departments and
CIOs within the healthcare enterprise."
In addition to the diagnostic benefits of flat-panel displays over
CRTs that were supported by Planar's clinical trials, flat panels are
a more attractive alternative for quality assurance. CRT monitors
degrade over time and require constant inspection and adjustments to
maintain optimal performance. Planar's entire Dome Cx line of
flat-panel monitors automatically calibrates with Dome CXtra(TM)
software to stay in conformance with Digital Imaging and
Communications in Medicine (DICOM) standards. The unique software
warns users of any deviation from DICOM parameters and produces
detailed log information for auditing purposes. Additionally, all of
Dome CXtra's quality-assurance functionality can be viewed and managed
remotely by IT and quality-assurance departments, reducing the total
cost of ownership of the displays.
With another industry first captured by the Dome displays for
diagnostic imaging, Planar is enabling a wider range of healthcare
facilities to deploy the finest medical displays for improved patient
care without compromising on the quality necessary to meet stringent
Planar's Dome C5i
The Dome C5i exceeds industry standards for diagnostic-quality
resolution recommended by the American College of Radiology and the
National Electrical Manufacturers Association (ACR-NEMA). It provides
3,061 distinct, displayable gray shades -- nearly three times that of
alternative 5MP flat-panel monitors. This provides for precise
calibration to DICOM standards, and allows radiologists to distinguish
slight variations in a patient's radiograph. Because of its
brightness, the Dome C5i can work equally well in bright areas as it
does in dark radiology reading rooms.
The line of Dome radiological displays is part of Planar's overall
suite of flat-panel based products that serve as the medical world's
gateway to patient information. The company's products, developed
specifically to meet the rigors of the medical market, also include
the VitalScreen(R) line of displays used for patient monitoring and
surgical applications, and the Invitium(R) family of point-of-care
systems. Planar also provides large plasma screens for patient
tracking applications, and desktop monitors used throughout hospital
Planar Systems, Inc. (Nasdaq:PLNR) is one of the world's most
accomplished providers of flat-panel displays with more than 20 years
expertise in flat-panel innovation. The company provides the most
dependable display solutions for demanding applications in industrial,
medical, commercial and consumer markets. Planar's customers depend on
its award-winning displays in mission-critical moments, from making
split-second medical decisions to catching late-breaking headlines.
Founded in 1983, Planar is a global company with headquarters in
Oregon. For more information, please visit www.planar.com.
CONTACT: Planar Systems, Inc.
Linda Ferguson, 503-748-7280 (Media)
Stewart Clark, 503-748-6984 (Investors)
Keith Wiley, 213-438-8823 (Media)
SOURCE: Planar Systems, Inc.