SuperSonic Imagine Receives FDA 510(k) Clearance for Breast- and Liver-Imaging Modes

SuperSonic Imagine Receives FDA 510(k) Clearance for Breast- and Liver-Imaging Modes

SuperSonic Imagine has received 510(k) clearance from the U.S Food and Drug Administration (FDA) for its Aixplorer platform imaging modes, including improved ones for breast imaging. The FDA’s clearance means the company’s new imaging modes, including the Angio PL.U.S. (PlaneWave UltraSensitive Imaging), TriVu, Fusion and Navigation, contrast liver imaging, and B-Mode Ratio, can now be marketed in the U.S.

“This clearance is the culmination of several years of research and development on our Aixplorer platform,” Jacques Souquet, founder and chief innovation officer for SuperSonic Imagine, said in a press release. “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,” he said.

SuperSonic Imagine’s Aixplorer is a ground-breaking ultrasound system platform that can acquire images 200 times faster than conventional ultrasound systems. Its unique technology is the foundation for several innovations that have changed the paradigm of ultrasound imaging: ShearWave Elastography (SWE), UltraFast Doppler, Angio PL.U.S and, more recently, TriVu.

The Real-time ShearWave Elastography, which has been in use since 2009, allows high-quality visualization of liver anatomy in real time, providing color and quantitative mapping of liver stiffness, which helps doctors assessing patients with diffuse liver disease, such as fibrosis.

With the addition of Angio PL.U.S. and contrast mode, however, physicians also will be able to image the vasculature and micro-vasculature of liver lesions, further improving doctors’ abilities to manage these patients.

The fusion and navigation on Aixplorer system also will improve such management by merging ultrasound images with other imaging methods, including magnetic resonance imaging (MRI), computerized tomography (CT), and positron emission tomography (PET) scans.

This FDA clearance also focuses on advancements in breast imaging. The new “breast pack” has improved probes and a real time TriVu mode, which combines anatomical and stiffness information, as well as Angio PL.U.S. microvascularization information, offering a novel and broad visualization of breast tissue lesions.

SuperSonic Imagine showcased its new imaging probes at the RSNA Congress (Radiological Society of North America) in Chicago, Nov. 27-Dec. 1.

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