Digirad Corporation Receives FDA 510(k) Clearance for nSPEED(R) Reconstruction Software for Improved Image Quality in Less Time
September 22 2008 - 1:30PM
PR Newswire (US)
To Market Imaging Systems Using New Software That Enables SPECT
Procedures That Meet New ASNC Technology Standards POWAY, Calif.,
Sept. 22 /PRNewswire-FirstCall/ -- Digirad Corporation
(NASDAQ:DRAD), a leading provider of diagnostic imaging systems and
services to physicians' offices, hospitals and other medical
services providers, today announced it received from the U.S. Food
and Drug Administration (FDA) 510(k) clearance for its new
nSPEED(R) reconstruction software -- for reduced imaging time and
improved image quality with less radiation exposure for patients --
to be used in its imaging systems for SPECT procedures at either
half-time and/or half count densities with parallel and
non-parallel hole collimators. SPECT (single photon emission
computed tomography) systems are commonly used to perform a
non-invasive test to assess the heart's structure and function. For
example, with nSPEED, Digirad Cardius solid-state dedicated cardiac
systems can now perform cardiac SPECT imaging procedures in as
little as three minutes or with one-half the required
pharmaceutical dosages. Supporting 510(k) documentation submitted
to the FDA was based on data obtained from a 448-patient, 10-center
evaluation using Digirad's single, dual and triple-head Cardius
cameras. Digirad Chief Executive Mark Casner stated: "Our nSPEED
software represents a new benchmark for performing nuclear SPECT
studies that meet the new standards recently issued by the American
Society of Nuclear Cardiology. In addition, with nSPEED which is an
advanced 3D-OSEM reconstruction program, the acquisition times for,
and count densities of, cardiac SPECT images represent a 50 percent
improvement over specifications in prior ASNC guidelines." On June
18, 2008, the American Society for Nuclear Cardiology (ASNC) issued
new technology-standards for SPECT image acquisition and
processing. This standard stated, "For new software methods
specifically designed for reduced acquisition times and/or lower
count density images, cardiac count density should be in accordance
with that specified in or implicit to the method's 510(k) FDA
approval." About Digirad Digirad Corporation provides diagnostic
nuclear and ultrasound imaging systems and services to physicians'
offices, hospitals and other medical services providers for
cardiac, vascular, and general imaging applications. Digirad's
Cardius XPO line of nuclear imaging cameras use patented
solid-state technology and unique multi (dual, triple) head design
for superior performance and advanced features for sharper digital
images, faster processing, compact size, lighter weight for
portability, ability to handle patients up to 500 pounds, and
improved patient comfort compared to standard nuclear cameras.
Digirad's 2020tc general-purpose nuclear imager has a small
footprint and may also be configured for fixed or mobile use to
supplement primary imaging. Digirad's installed base of equipment
exceeds 550 systems; in addition, a mobile fleet of 164 nuclear and
ultrasound imaging systems is being used in 22 states and the
District of Columbia, primarily in the eastern, midwestern and
southwestern United 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 Statements in this press release that
are not a description of historical facts are forward looking
statements. You can identify these statements by the fact that they
do not relate strictly to historical or current facts and use words
such as "anticipate," "estimate," "expect," "project," "intend,"
"plan," "believe" and other words and terms of similar meaning.
Examples of such forward looking statements include statements
regarding improvements in performance and results of actual use.
Actual performance, results and benefits results may differ
materially from those set forth in this press release due to risks
and uncertainties inherent in the use of new technology, working
conditions, work force, 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, 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: Dan Matsui Todd Clyde, CFO Allen & Caron 858-726-1600
949-474-4300 DATASOURCE: Digirad Corporation CONTACT: Investors,
Dan Matsui of Allen & Caron, +1-949-474-4300, for Digirad
Corporation; or Company, Todd Clyde, CFO of Digirad Corporation,
+1-858-726-1600, Web site: http://www.digirad.com/
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