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.
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