Digirad Receives 510(k) for Cardius X-ACT Rapid Cardiac SPECT/VCT Imager
March 26 2009 - 6:00AM
PR Newswire (US)
FDA Clearance Allows Digirad to Market New Imaging System POWAY,
Calif., March 26 /PRNewswire-FirstCall/ -- Digirad Corporation
(NASDAQ:DRAD), a leading provider of medical diagnostic imaging
products and personnel and equipment leasing services that improve
patient care while driving positive healthcare economics, today
announced that it has received 510(k) clearance from the US Food
and Drug Administration (FDA), enabling the Company to market and
manufacture its Cardius(R) X-ACT imaging system. Cardius X-ACT is a
rapid cardiac SPECT/VCT imaging system that features a low-dose
volume-computed tomography (VCT) attenuation correction system that
significantly reduces artifacts in the images caused by overlying
tissues increasing interpretive ease and accuracy. The
revolutionary X-ACT approach takes advantage of the full 24-inch
wide detector array eliminating truncation and generating
high-precision transmission maps improving the overall quality of
SPECT studies. The X-ACT attenuation correction system offers high
accuracy, fast acquisition, low dose (5 uSv / study) and superb
reliability. The system's high-speed triple-head solid-state design
combined with nSPEED(R) software allows the combined cardiac SPECT
emission and transmission acquisitions to be performed in as little
as five minutes. The Cardius X-ACT system increases diagnostic
confidence in nuclear cardiology and raises the standard in the
industry for overall SPECT system performance. Digirad is working
with a number of top luminary centers in nuclear cardiology,
including the Biomedical Institute in Los Angeles, Jefferson Heart
Institute in Philadelphia and University Cardiovascular Medical
Group of UCLA in Los Angeles. Results of an extensive multi-center
evaluation of the X-ACT technology will be presented during
upcoming events including ACC in Orlando, ICNC 2009 in Barcelona,
SNM 2009 in Toronto and ASNC 2009 in Minneapolis. Digirad CEO Todd
P. Clyde stated, "The X-ACT system is an important step forward in
our strategy to drive the evolution of nuclear cardiac imaging by
introducing a series of advanced solid state cameras that are
distinguished by their ability to increase diagnostic accuracy;
make earlier detection of disease possible; or by providing new
clinical information that raises sensitivity or specificity of
nuclear cardiology procedures. We believe that innovations from our
technology group will enable us to expand our market share in the
hospital and large practice segments. The X-ACT system is a great
example of this initiative as it can provide cutting-edge VCT
technology to a broader range of practices and facilities, allowing
higher patient throughput and a better level of care at comparable
pricing to less accurate technologies." About Digirad Corporation
Digirad markets medical diagnostic imaging systems and personnel
and equipment leasing services for cardiac, vascular, and general
imaging applications. Digirad's Cardius XPO line of nuclear imaging
cameras use patented solid-state technology for superior
performance resulting in sharp digital images, fast processing,
compact size, light weight for portability and ability to handle
patients up to 500 pounds; Digirad's installed base of equipment
exceeds 600 systems. Digirad also performs leasing services with
its portable fleet of more than 145 nuclear and ultrasound imaging
systems in 21 states. For more information, please visit
http://www.digirad.com/. Digirad(R), Digirad Imaging Solutions(R),
and Cardius(R) are registered trademarks of Digirad Corporation.
Forward-Looking Statements This press release contains statements
that are forward-looking statements as defined within the Private
Securities Litigation Reform Act of 1995. These include statements
regarding the efficacy of Digirad's centers of influence model, the
status of the negotiation of the sale or closure of underperforming
hub locations, and the ability to achieve positive cash flow and
profitability, drive technology progress and improve services
utilization to grow market share. These forward-looking statements
are subject to risks and uncertainties that could cause actual
results to differ materially from the statements made, including
the risks associated with changes in business conditions,
technology, customers' business conditions, work force, suppliers,
business prospects, economic outlook, operational policy or
structure, acceptance and use of Digirad's camera systems and
services, reliability, recalls, and other risks detailed in
Digirad's filings with the U.S. Securities and Exchange Commission,
including Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, Current Reports on Form 8-K and other reports. Readers are
cautioned to not place undue reliance on these forward looking
statements, which speak only as of the date hereof. All forward
looking statements are qualified in their entirety by this
cautionary statement, and Digirad undertakes no obligation to
revise or update the forward looking statements contained herein.
Investor Contact: Company Contact: Matt Clawson Todd Clyde Allen
& Caron Chief Executive Officer 949-474-4300 858-726-1600
DATASOURCE: Digirad Corporation CONTACT: Investors, Matt Clawson of
Allen & Caron, +1-949-474-4300, for Digirad Corporation; or
Todd Clyde, Chief Executive Officer of Digirad Corporation,
+1-858-726-1600 Web Site: http://www.digirad.com/
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