Healthcare Industry News:  computed tomography 

Devices Radiology Cardiology FDA

 News Release - March 26, 2009

Digirad Receives 510(k) for Cardius X-ACT Rapid Cardiac SPECT/VCT Imager

FDA Clearance Allows Digirad to Market New Imaging System

POWAY, Calif., March 26 (Healthcare Sales & Marketing Network) -- 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® 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® 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 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.


Source: Digirad

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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