Digirad Corporation Receives FDA 510(k) Clearance for nSPEED(R) Reconstruction Software for Improved Image Quality in Less Time With Less...( To Market Imaging Systems Using New ...),Health

To Market Imaging Systems Using New Software That Enables SPECT Procedures

That Meet New ASNC Technology Standards

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 guideli
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