SuperSonic Imagine wins expanded FDA nod for Aixplorer platform

SuperSonic Imagine said today it won expanded FDA 510(k) clearance for its Aixplorer platform, including clearance for additional probes and multiple new imaging modes.

The new clearance includes the French company’s Angio PL.U.S PlaneWave imaging, TriVu imaging, fusion and navigation imaging, contrast liver imaging and B-Mode ratio imaging.

The newly cleared Angio PL.U.S. and contrast mode allow operating physicians to visualize the vascularization and micro-vascularization of liver lesions, the company said. The fusion and navigation imaging allows for the ability to merge ultrasound images with other imaging modalities, including CT, MR and PET.

Other cleared improvements include a breast imaging improvements, which includes a real-time TriVu mode that combines anatomical information, stiffness information and Angio PL.U.S. microvascularization information, the company 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,” founder & chief innovation offier Jacques Souquet said in a press release.

In May, SuperSonic Imagine said it won regulatory approval in Japan for its most recent Aixplorer ultrasound system, which includes new features that allow for the evaluation of liver disease, prostate cancer, obstetrics and musculoskeletal assessment.

In March, SuperSonic Imagine said it inked a U.S. distribution deal with Sandhill Scientific to distribute its Aixplorer ShearWave Elastography-equipped ultrasound system designed to assess liver disease, along with releasing its 2015 earnings.

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