FDA Clears Aixplorer Ultrasound with MultiWave Technology

August 26, 2009 - SuperSonic Imagine announced today the FDA has granted 510(k) clearance for its Aixplorer ultrasound system and will begin to market and deliver the device in the United States.

Aixplorer offers MultiWave Technology, which is based upon interaction between conventional longitudinal waves and shear waves in tissue. The system consists of an all software-based architecture which provides both impeccable B-mode images and, for the first time, displays tissue stiffness or elasticity information using shear waves. As stiffness is an additional parameter which characterizes tissue, Aixplorer brings clinicians significantly enhanced diagnostic information.

Aixplorer’s SonicSoftware, the power behind MultiWave Technology, has leverage the technology in the graphic games industry and the latest generation of multi-core processors to provide a complete ultrasound system with enhanced speed, accuracy and flexibility. The innovation is said to provide improved B-mode image clarity and an open door to new imaging modalities.

Speed, accuracy and flexibility play a large role in what many regard as Aixplorer’s outstanding B-mode image quality. It brings fundamental improvements to traditional imaging by software that improves conspicuity, lateral and contrast resolution and delineation of structures to better characterize tissue. MultiWave imaging also supports TissueTuner, a tool to adjust the system’s parameters to accurately match the speed of sound in the tissue being imaged.

While shear waves naturally exist in the human body, SuperSonic Imagine’s development of new MultiWave ultrasound technology produces images which leverage the interaction between longitudinal waves or B-Mode with shear waves. Aixplorer can generate, capture and compute shear wave velocity resulting in the bi-dimensional display of true tissue elasticity.

ShearWave Elastography is different from conventional or strain elastography which relies on manual compression for palpation and is therefore subjective and operator dependent. Instead, ShearWave Elastography is user-skill independent as it does not rely on compression but is based on the simultaneous use of both ultrasound waves and shear waves to assess tissue stiffness. ShearWave Elastography uses remote palpation to provide an objective assessment of tissue stiffness in real time using color-coded mapping. In addition, results are reproducible and lesions can be monitored over time.

Aixplorer is designed to offer the following:

• lesion characterization through clarity, improved conspicuity, and better delineation of normal and abnormal structures
• sharper borders and superior lateral and contrast resolution in different tissue densities from fatty to dense
• simultaneous resolution while in B-mode, Color and Power Doppler
• imaging in ShearWave Elastography displaying local tissue elasticity in real time
• reproducible results that can be tracked over time
• user skill independence
• time-saving easy upgrades of software
• easy reporting with software-integrated BI-RADS
• intuitive ergonomic design for comfort and ease of use

For more information: www.supersonicimagine.com