To Market Imaging Systems Using New Software That Enables SPECT Procedures That Meet New ASNC Technology Standards POWAY, Calif., Sept. 22
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 & Caron858-726-1600
949-474-4300 ir@digirad.com
SOURCE Digirad Corporation
