SuperSonic Imagine Receives FDA 510(k) Clearance for its new Innovative Breast and Liver package on Aixplorer

AIX-EN-PROVENCE, FRANCE--(Marketwired - Nov 21, 2016) -  SuperSonic Imagine (EURONEXT PARIS: SSI) (FR0010526814), a company specializing in ultrasound medical imaging, today announced that it has received 510(k) clearance from the Food & Drug Administration (FDA) for additional probes and significant clinical innovations on the Aixplorer® platform. This authorization includes numerous new imaging modes recently developed by SuperSonic Imagine:

• Angio PL.U.S. - PlaneWave UltraSensitive™ Imaging
• TriVu
• Fusion and Navigation
• Contrast liver imaging
• B-Mode Ratio.

"This clearance is the culmination of several years of research and development on our Aixplorer platform," said Jacques Souquet, Founder and Chief Innovation Officer for SuperSonic Imagine. "These new imaging modes provide unique information for the clinical management of patients with Breast and Liver disease. In particular, this new release will position SuperSonic Imagine as a leading innovator in the field of chronic liver diseases management and cover the whole spectrum of liver diseases from NAFLD to HCC. We are extremely pleased that we can now bring the latest upgrades to the United States market and its patients and provide the clinical community with the most advanced tools available."

With ShearWave™ Elastography (SWE™) in use since 2009, Aixplorer allows visualization of liver anatomy in real time, while providing color and quantitative mapping of liver stiffness, an important parameter which helps physician in their imaging of patients with diffuse liver disease such as fibrosis. To date, nearly 100 international publications have demonstrated the reliability and effectiveness of SuperSonic Imagine's SWE in this field. This latest version of Aixplorer ulltrasound system will further extend the diagnostic possibilities on patients with chronic liver disease by providing an assessment of the liver echostructure which changes in patients with steatosis. With Angio PL.U.S. and contrast mode, doctors will be able to also visualize the vascularization and micro-vascularization of liver lesions. The fusion and navigation on Aixplorer provides the ability to merge ultrasound images with other imaging modalities (CT, MR, PET), and will allow users to use the equipment in the field of interventional radiology.