Print This Story  Email This Story  Save this Link View PR Newswire's RSS Feed  Blogs Discussing this News Release  Search Blogs that Mention this News Release  Click this link to view linked Bookmarking Services Click this link to view linked Blogging Services


Spectrum Dynamics Receives 510(K) Clearance for the D-SPECT(TM) Cardiac System

    CHICAGO, Nov. 27 /PRNewswire/ -- 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.


SOURCE Spectrum Dynamics




Back to Topback to top

Related links:
  • http://www.spectrum-dynamics.com/
    CONTACT:
    Josh Gurewitz, Vice President of Marketing of
    SPECTRUM DYNAMICS, +1-925-831-0515, or
    JoshG@spectrum-dynamics.com