Digirad Receives FDA Clearance for Ergo Large Field-of-View, Solid-State, General Imaging Nuclear Medicine Camera
April 26 2010 - 6:00AM
Marketwired
Digirad Corporation (NASDAQ: DRAD), a diversified health care
company specializing in the early detection of disease to enhance
quality of life, today announced that it has received 510(k)
clearance from the U.S. Food and Drug Administration (FDA),
enabling the Company to market and distribute its ergo™ large
field-of-view, general-purpose portable imaging system.
Digirad's ergo marks the beginning of a new era of freedom for
nuclear medicine. The advent of a large field, solid-state portable
general-purpose camera that makes it possible to "image without
boundaries" for such a diverse range of procedures is a significant
breakthrough for the nuclear specialty. The ergo's unique
ergonomic, lightweight portable design enables imaging to be
performed in the nuclear department and outside (ICU, CCU, OR, ER,
pediatrics, trauma units, patient floors, ambulatory services,
women's health or research areas). To top it off, the ergo expands
clinical utility and performance to a level that was until now, not
possible. The ergo applies breakthrough solid-state technology in a
manner that delivers real gains in patient comfort, clinical
flexibility and diagnostic quality.
Digirad CEO Todd P. Clyde stated, "The ergo system is an
important milestone in our strategy to expand our business in the
hospital sector by introducing a series of advanced solid-state
cameras that are distinguished by their ability to deliver higher
clinical value and return on investment than conventional
photomultiplier-based camera technologies generally in use today.
The ergo provides institutions with the means to dramatically
reduce costs for many procedures, improve patient satisfaction,
raise productivity and flexibility, and the capability to generate
revenues from new procedures -- all critical considerations for
hospitals today."
The heart of the ergo is its large 12.25 inch by 15.5 inch
field-of-view, Digirad's most advanced solid-state detector
technology ever. The system delivers unsurpassed performance
specifications for general imaging with intrinsic spatial
resolution of 3.25 mm, energy resolution of 7.9% and count rate
capabilities of 5 Mcps. The end result is consistent outstanding
quality nuclear studies for every patient -- everyday. The ergo's
unique design features three compound detector motions and a
portable base to introduce a level of detector positional
flexibility, unmatched by any other system. Digirad plans to ship
its first production systems beginning in June of this year to a
number of leading medical centers in the US and abroad.
Clyde concluded, "The ergo represents a whole new level of
freedom both within the nuclear department and outside. The
expanded clinical flexibility the system affords introduces
exciting new imaging possibilities for a wide variety of
procedures. The cost, size and flexibility of the ergo system will
be attractive to institutions seeking innovative ways to improve
quality, increase productivity and improve patient care."
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 700
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 www.digirad.com.
Digirad®, Digirad Imaging Solutions®, and Cardius® 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: Matt Clawson Allen & Caron
949-474-4300 Company Contact: Todd Clyde Chief
Executive Officer 858-726-1600
Digirad (NASDAQ:DRAD)
Historical Stock Chart
From Jun 2024 to Jul 2024
Digirad (NASDAQ:DRAD)
Historical Stock Chart
From Jul 2023 to Jul 2024