Digirad Corporation Receives U.S. FDA 510(k) Market Clearance for Expanded Uses
of ergo(TM) Imaging System
POWAY, CA -- (Marketwire) -- 01/31/13 -- Digirad Corporation
(NASDAQ: DRAD), a leading provider of diagnostic imaging products,
and personnel and equipment leasing services, today announced that it
received U.S. FDA 510(k) market clearance to further expand the
clinical flexibility of the ergo(TM) Imaging System for applications
throughout the hospital, including the areas of nuclear medicine,
surgery and women's health.
The clearance includes indications for lymphatic scintigraphy and
parathyroid scintigraphy, both nuclear diagnostic imaging tests, and
to aid in the evaluation of lesions in the breast and other small
body parts. The ergo(TM) can also be used intra-operatively when
protected by sterile drapes. When used for breast imaging, the
ergo(TM) System is indicated to serve as an adjunct to mammography or
other primary breast imaging modalities.
Todd Clyde, Chief Executive Officer of Digirad, indicated that the
ergo(TM) system was always envisioned as a multi-use, portable camera
with a wide variety of clinical capabilities and operational
efficiencies. The new indications add to the "image without
boundaries" concept of the large field, solid-state ergo device.
"The ergo(TM) Imaging System is a perfect example of our continuous
efforts to provide our customers with new ways to attain further
improvements in clinical and financial outcomes," Clyde said. "The
ergo Imaging System allows physicians to rethink traditional
practices regarding how and where an imaging system is used. As a
leader in diagnostic imaging, we are dedicated to developing and
marketing new and innovative products that enhance life by
dramatically improving the diagnosis and treatment of disease."
The ergo(TM) Imaging System provides powerful new solid-state
technology substantially raising overall performance capabilities and
significantly lowering total lifecycle costs. The Large Field of View
(LFOV) camera (12.25" x 15.5") provides ideal utility for a wide
range of procedures performed in nuclear medicine or throughout the
hospital. The sleek, open gantry/detector design is patient friendly
and convenient to image patients sitting up and lying on stretchers
or beds. I
ts lightweight, portable design makes it possible to use in
nearly any room or department.
The portable design of the ergo(TM) Imaging System offers the
potential to increase return on investment, reduce operational costs,
and increase study volume over traditional fixed assets.
Digirad is a leading provider of diagnostic imaging products, and
personnel and equipment leasing services. For more information,
please visit www.digirad.com. Digirad(R) is a registered trademark of
About ergo(TM) Imaging System
The ergo(TM) Imaging System is Digirad's most advanced nuclear
medicine camera featuring the Large Field of View (LFOV) solid-state
detector. The system provides superior image contrast and clarity for
general imaging. Five easy to change, high performance collimator
options provide the capability to provide outstanding imaging quality
for a wide range of procedures with energy ranges from 50 to 350 keV.
Designed for versatility, the open gantry, long 48" reach and
multiple compound motions provide enhanced positional flexibility to
address various applications and patient settings. Lightweight and
portable, the ergo(TM) Imaging System can be easily moved throughout
the hospital maximizing the system's utility and convenience. The
ergo(TM) Imaging System delivers improved clinical outcomes, imaging
without boundaries and a significant return on investment.
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Allen & Caron
Todd P. Clyde
Chief Executive Officer
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