Spectrum Dynamics Receives 510(K) Clearance For The D-SPECT(TM) Cardiac System

November 29, 2006 – 10:54 pm | posted in Cardiovascular, Radiology

SPECTRUM DYNAMICS today announced at the Radiological Society of North America (RSNA) annual meeting in Chicago that its D-SPECT(TM) Cardiac System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), and is expected to begin commercial shipments next year once the initial clinical studies are completed. The D-SPECT system with BroadView(TM) imaging technology represents a breakthrough in almost every component of nuclear cardiology imaging workflow and diagnostics.

The D-SPECT is an entirely new technology designed to transform the nuclear medicine imaging market by significantly reducing acquisition time while improving sensitivity and resolution. “We are pleased that Spectrum Dynamics has obtained 510(k) clearance for the D-SPECT Cardiac System and we are confident that the D-SPECT will be extremely well received by the nuclear medicine marketplace,” states Dr. Michael (”Miki”) Nagler, CEO of SPECTRUM DYNAMICS.

BroadView imaging technology provides significantly improved sensitivity by collecting photons using larger collection angles, a novel design of scanning solid state detectors and proprietary image reconstruction techniques. This technology has produced an imaging platform capable of acquiring patient data up to 10 times faster than a conventional sodium iodide based system, and with up to twice the resolution. “The D-SPECT opens the door to new possibilities and enables high definition personalized imaging and the use of low-dose radiopharmaceuticals,” states Josh Gurewitz, Vice President of Marketing. “In the future, dynamic imaging and the use of multiple radiopharmaceutical cocktails will create vast opportunities for new diagnostic procedures.”

For more information about D-SPECT visit SPECTRUM DYNAMICS at booth #3380 at the RSNA annual meeting.

About SPECTRUM DYNAMICS

SPECTRUM DYNAMICS will revolutionize the practice of nuclear cardiology, and eventually all nuclear medicine applications, by dramatically enhancing workflow and providing new clinical applications not possible with conventional technology. SPECTRUM DYNAMICS, with offices in New York, California and research and development facilities in Haifa Israel is a pioneering medical device company focused on personalized molecular imaging and applications. Additional information can be found at http://www.spectrum-dynamics.com/.

Forward-Looking Statements

This press release may contain forward-looking statements about SPECTRUM DYNAMICS, including projections about our business and the nuclear medicine market. Those forward-looking statements are not guarantees of future performance and actual results could differ.

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