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Fujifilm Receives FDA Clearance for Synapse® 3D


News provided by

FUJIFILM Medical Systems U.S.A., Inc.

Nov 28, 2010, 08:55 ET

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CHICAGO, Nov. 28, 2010 /PRNewswire/ -- Radiologists and cardiologists alike can expect to experience clinical and workflow improvements from Synapse® 3D, the latest addition to the expanding medical informatics product line from FUJIFILM Medical Systems U.S.A., Inc.  Now FDA 510(k) cleared for sale in the U.S., Synapse 3D is a comprehensive suite of clinical applications that is integrated directly into both Synapse® PACS and Synapse® Cardiovascular(1), providing access to advanced diagnostic tools without the need for separate workstations.

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(Photo: http://photos.prnewswire.com/prnh/20101128/NY07707 )

Fujifilm is one of the first major PACS vendors to introduce its own advanced visualization product.  Because it is vendor-neutral and multi-modality capable, Synapse 3D can be used with virtually any advanced imaging system, such as PET, CT, MR and nuclear medicine.  Included in the suite of radiology and cardiology applications is an unprecedented amount of diagnostic clinical tools ranging from 2D, 3D, and 4D viewing, to Dynamic Data, Fusion (including PET, MR, CT and SPECT), and Sector MPR (multi-planar reconstruction).

"To assure our success in the advanced visualization market, Fujifilm made it a priority to gather extensive input from radiologists, cardiologists and surgeons when developing Synapse 3D.  We then took what we heard and applied our unique capabilities to it," said Jim Morgan, Fujifilm's Vice President, Medical Informatics.  "Fujifilm has integrated Synapse 3D directly into our PACS and CVIS to improve workflow and accessibility, and we've drawn on our proven strengths in image processing and analysis to deliver superior clinical results," explained Morgan.

Because Synapse 3D is integrated directly into Synapse® PACS and Synapse® Cardiovascular, it is enterprise capable, and is available at any workstation where Synapse PACS is available, including at home or from remote locations.  From the Synapse power jacket or "quick launch" mode, it can readily be accessed with just one click, providing a more efficient workflow for clinicians by eliminating the need to access separate workstations with additional logons, while still maintaining security levels.  It also automatically imports the advanced analysis back into the Synapse PACS and CVIS systems, creating one common information database and image storage location.

Clinical and diagnostic benefits are added from Fujifilm's ability to leverage their 30-plus year history of image processing with the development of Synapse 3D.  Image Intelligence, Fujifilm's proprietary algorithms, has been used to deliver image visualization benefits such as precise segmentation and analysis.  Additionally, powered by server-based rendering technology, Synapse 3D enables the radiologist/cardiologist or the technologist to perform the renderings.

Already installed at more than 200 facilities around the world, Synapse 3D is anticipated to see widespread adoption at hospitals and practices across the U.S.  At Los Angeles County Hospital (LAC) and University of Southern California (USC) Medical Center, doctors have been using the advanced application for clinical trials and are now preparing widespread rollout of the technology.

"Synapse 3D has proven to be an incredibly valuable tool during our research, particularly its PET-MR fusion capabilities for diagnosing epilepsy and the utility of neurovascular calcium scoring(1) for predicting stroke," said Meng Law, MD, Director of Neuroradiology, LAC+USC Healthcare Network. "The powerful and efficient post-processing capabilities have allowed us to see much more information to better support our diagnosis and patient care decisions, in some cases even enabling us to avoid surgeries.  We're all looking forward to the wide-scale rollout and the regular use of Synapse 3D by countless physicians and specialists across the LAC+USC Healthcare Network."

About FUJIFILM

FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of diagnostic imaging products and medical informatics solutions to meet the needs of healthcare facilities today and well into the future. From an unrivaled selection of digital x-ray systems, to the Synapse® brand of PACS, RIS and cardiovascular products, to advanced women's health imaging systems, Fujifilm has products that are ideal for any size imaging environment. FUJINON is a subsidiary of FUJIFILM Medical Systems U.S.A., Inc., and supplies technologically advanced endoscopes to the medical market. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Stamford, CT.

© 2010 FUJIFILM Medical Systems U.S.A., Inc.  

(1) The Cardiovascular applications and Calcium Scoring are pending FDA 510(k) clearance and are not available for sale in the U.S.

SOURCE FUJIFILM Medical Systems U.S.A., Inc.

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