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Digirad Receives 510(k) for Cardius X-ACT Rapid Cardiac SPECT/VCT Imager
Date:3/26/2009

FDA Clearance Allows Digirad to Market New Imaging System

POWAY, Calif., March 26 /PRNewswire-FirstCall/ -- 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(R) 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(R) 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
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SOURCE Digirad Corporation
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