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SuperSonic Imagine obtains FDA clearance for Aixplorer’s ShearWave elastography

SuperSonic Imagine, a medical ultrasound company, announced its Aixplorer MultiWave ultrasound system has obtained the US Food and Drug Administration (FDA) approval for the quantification capabilities of its real-time ShearWave Elastography (SWE).

The Aixplorer’s UltraFast imaging platform can produce images up to 200 times faster when compared to a conventional ultrasound.

It is reportedly the only system to genearte shear waves in tissue in real-time and simultaneously image and compute the velocity of these waves.

SWE permits non-invasive electronic palpation, even in deep, hard to reach organs, and this palpation displays real-time, quantitative (kPa) tissue elasticity on a color-coded map and aids physicians in their diagnostic process, as tissue stiffness varies with the severity of pathology.

Additionally, SWE imaging provides clinical advantages for ultrasound-guided procedures, evaluation of multifocal stiff tissue, dynamic analysis of elasticity changes and longitudinal follow-up of tissue abnormalities and treatment.

SWE has also demonstrated its added value for lesion characterization in a large, multicenter clinical trial.

SuperSonic Imagine president and CEO Jacques Souquet noted that as an innovative company, it is very proud to see the FDA recognition of the clear benefits its disruptive technology brings to the medical profession.

"Physicians have assessed the clinical value of real-time, quantitative ShearWave Elastography on more than 700 Aixplorers worldwide and have validated SuperSonic Imagine as the leader in shear wave based ultrasound elastography," Souquet added.

The Aixplorer MultiWave ultrasound system received the FDA approval in 2009.