Healthcare Industry News: computed tomography
News Release - September 22, 2008
Digirad Corporation Receives FDA 510(k) Clearance for nSPEED(R) Reconstruction Software for Improved Image Quality in Less Time With Less RadiationTo Market Imaging Systems Using New Software That Enables SPECT Procedures That Meet New ASNC Technology Standards
POWAY, Calif., Sept. 22 (HSMN NewsFeed) -- 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® 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 guidelines."
On June 18, 2008, the American Society for Nuclear Cardiology (ASNC) issued new technology-standards for SPECT image acquisition and processing. This standard stated, "For new software methods specifically designed for reduced acquisition times and/or lower count density images, cardiac count density should be in accordance with that specified in or implicit to the method's 510(k) FDA approval."
Digirad Corporation provides diagnostic nuclear and ultrasound imaging systems and services to physicians' offices, hospitals and other medical services providers for cardiac, vascular, and general imaging applications. Digirad's Cardius XPO line of nuclear imaging cameras use patented solid-state technology and unique multi (dual, triple) head design for superior performance and advanced features for sharper digital images, faster processing, compact size, lighter weight for portability, ability to handle patients up to 500 pounds, and improved patient comfort compared to standard nuclear cameras. Digirad's 2020tc general-purpose nuclear imager has a small footprint and may also be configured for fixed or mobile use to supplement primary imaging. Digirad's installed base of equipment exceeds 550 systems; in addition, a mobile fleet of 164 nuclear and ultrasound imaging systems is being used in 22 states and the District of Columbia, primarily in the eastern, midwestern and southwestern United States. For more information, please visit http://www.digirad.com. Digirad®, Digirad Imaging Solutions®, and Cardius® are registered trademarks of Digirad Corporation.
Statements in this press release that are not a description of historical facts are forward looking statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts and use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" and other words and terms of similar meaning. Examples of such forward looking statements include statements regarding improvements in performance and results of actual use. Actual performance, results and benefits results may differ materially from those set forth in this press release due to risks and uncertainties inherent in the use of new technology, working conditions, work force, 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, 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.
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