FDA OK's SuperSonic's new ultrasound probes

Ultrasound technology developer SuperSonic Imagine has received U.S. Food and Drug Administration (FDA) 510(k) clearance for additional probes and clinical updates on its Aixplorer scanner.

The authorization includes the following new imaging modes:

  • Angio PlaneWave UltraSensitive (PL.U.S.) imaging
  • TriVu
  • Fusion and navigation
  • Contrast liver imaging
  • B-mode ratio

The latest version of the Aixplorer ultrasound system will further aid the diagnosis of 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 visualize the vascularization and microvascularization of liver lesions, the firm said. The fusion and navigation mode on Aixplorer provides the ability to merge ultrasound images with those from other imaging modalities (CT, MR, and PET) and will allow clinicians to use the equipment in interventional radiology.

Other advancements focus on breast imaging. The new breast pack combines optimized probes and a real-time TriVu mode, which joins anatomical information, stiffness information, and Angio PL.U.S. microvascularization information, SuperSonic said.

At RSNA 2016, the company plans to showcase the new imaging modes and probes cleared by the FDA.

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