SuperSonic Imagine has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new breast and liver package on the Aixplorer platform.
The authorization features several new imaging modes that the company recently developed including Angio PLUS – Plainwave UltraSensitive Imaging, TriVu, Fusion and Navigation, Contrast Liver Imaging and B-Mode Ratio.
Aixplorer helps in visualising liver anatomy in real time, with the ShearWave Elastography (SWE) technology.
The device offers colour and quantitative mapping of liver stiffness, which is an important parameter for the physician in the diagnosis of diffuse liver diseases such as fibrosis.
The latest version of the device with further extensions is capable of increasing diagnostic possibilities in chronic liver diseases by assessing the liver echostructure which changes in patients with steatosis. Angio PLUS and contrast mode help doctors see vascularisation and micro-vascularisation of liver lesions.
Aixplorer also has the capability to merge ultrasound images with other imaging modalities such as CT, MR and PET and allows physicians to use equipment in interventional radiology.
Other add-on package which received compliance status is breast imaging. The new breast pack has optimised probes. Real time TriVu mode integrates anatomical information, stiffness information and Angio PLUS microvascularisation information.
TriVu mode also offers a comprehensive visualisation of breast lesions which have not been proposed in the field of ultrasound, according to the company.
The new probes and modes to have received the USFDA clearance will be put on display at Radiology Society of North America (RSNA) congress between November 27 and December 1 in Chicago.
SuperSonic Imagine founder and chief innovation officer Jacques Souquet said: “This clearance is the culmination of several years of research and development on our Aixplorer platform.
"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."