Innovative Ultrasound Company SuperSonic Imagine Receives FDA Clearance to Enhance ShearWave Elastography Imaging With a Real-Time Adjustable Numerical Scale (ANS)
9/20/2012 10:36:47 AM
For the first time ever, an numerical scale in meters per second can be used to optimize ShearWaveTM Elastography Images for better tissue stiffness display.
AIX-EN-PROVENCE, France--(BUSINESS WIRE)--SuperSonic Imagine, the innovative ultrasound imaging company, today announced that it has received FDA clearance for the addition of a Real-Time, Adjustable Numerical Scale in meters per second (ANSTM) for ShearWaveTM Elastography on the Aixplorer®.
In 2009, SuperSonic Imagine made worldwide headlines with its FDA cleared Aixplorer® Ultrasound System, the only system on the market with an UltraFast™ platform, capable of acquiring images up to 20,000 Hz, 100 times faster than conventional ultrasound.
With these capabilities, the Aixplorer can provide clinically detailed B-mode image quality and major technological achievements such as UltraFastTM Doppler and Real-Time, SuperSonic ShearWaveTM Elastography (SWE TM).
SuperSonic ShearWaveTM Elastography is a proven, leading technology that uses shear wave velocity measurements to assess tissue stiffness in real time on a color-coded map. ShearWaveTM Elastography has been used in various organs including the liver, prostate, thyroid and breast with promising and compelling clinical results. As a user-skill independent, reproducible technique, that is available on ALL of Aixplorer’s transducers, SWE™ has been a source of essential information for physicians as stiffer tissue can be related to various pathologies.
Now, with a real-time, adjustable numerical scale, Aixplorer® can display shear wave velocity in meters per second using an optimal color-coded dynamic range. Clinicians can adjust the scale to optimize visualization of tissue elasticity according to the organ of interest for several clinical applications.
For example, while imaging the liver, users will be able to easily and quickly adjust the scale when a liver nodule is seen in a fibrotic or cirrhotic context, as these nodules could be stiffer or softer than the surrounding tissue.
In addition, the real-time adjustable numerical scale will allow the user to repeat examinations with the same imaging display parameters.
SuperSonic ShearWaveTM Elastography is the first and only elastography the FDA has ever cleared with an adjustable numerical scale.
“This clearance is the result of a very constructive interaction with the FDA. We are also strongly involved in an effort launched by the RSNA to promote the use of quantification of shear wave speed measurement as biomarkers in different pathologies” stated Claude Cohen-Bacrie Executive VP of SuperSonic Imagine.
Jacques Souquet, CEO of SuperSonic Imagine added, “We are very excited that physicians in the USA will now have an additional tool to help them in their imaging of pathology. Our company strives to always bring the most innovative, clinically focused capabilities possible to ultrasound imaging.”
SuperSonic ShearWaveTM Elastography Imaging with a Real-Time Adjustable Numerical Scale (ANS) can be seen at the AASLD and RSNA in November 2012.
About SuperSonic Imagine
Founded in 2005 and based in Aix-en-Provence (France), SuperSonic Imagine is an innovative, international company specializing in ultrasound medical imaging. The company designs, develops and markets a revolutionary ultrasound system, Aixplorer®, with a unique ultrasound imaging technology, called MultiWave™ Technology. This technology allows Aixplorer® to be the only ultrasound system that images two types of waves to better characterize tissue; an ultrasound wave to ensure impeccable image quality and a shear wave, ShearWave™ Elastography, to compute and display true tissue stiffness in real time by acquiring images nearly 200 times faster than conventional systems.
ShearWave™ Elastography and UltraFast™ Doppler made possible by Aixplorer’s technology, allow physicians to visualize and analyze in real-time, thanks to a reliable, reproducible and extremely rapid process, the stiffness and vascularization of tissue in order to significantly improve the detection and characterization of numerous pathologies. The company has developed many clinical applications, including for the breast, thyroid, liver and prostate. In 2009, SuperSonic Imagine was granted 510(k) clearance by the Food and Drug Administration in the United States and CE mark in Europe for the marketing of Aixplorer®.
Distribution agreements have been signed with prestigious companies such as Hologic (Nasdaq : HOLX) for the breast market in the U.S.A. and Canon (NYSE : CAJ) for Japan.
SuperSonic Imagine holds the exclusive right, title and interest to 28 international patents and submissions in diagnostic imaging and therapy applications.
For more information about SuperSonic Imagine, please go to www.supersonicimagine.fr
Dan Conley, +1-312-593-8461
Michele Debain, +33 442 99 24 32
Global Marketing Director