FDA News

FDA grants 510(k) clearance to new ultrasound modes for liver, breast imaging

SuperSonic Imagine announced the FDA granted 510(k) clearance to add additional imaging probes — for liver disease and breast lesions — for use with its Aixplorer platform.

Aixplorer (SuperSonic Imagine) is an ultrasound system that uses an UltraFast (SuperSonic Imagine) platform for the acquisition of images at a rate 200 times faster than other ultrasound systems. The clearance includes the following imaging modes to be used with the system: PlaneWave UltraSensitive Imaging (SuperSonic Imagine), TriVu, fusion and navigation, contrast liver imaging and B-mode Ratio, according to a press release.

“These new imaging modes provide unique information for the clinical management of patients with breast and liver disease,” Jacques Souquet, founder and chief innovation officer at SuperSonic Imagine, said in the release. “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 [nonalcoholic fatty liver disease] to [hepatocellular carcinoma].”

The Aixplorer system currently allows liver anatomy to be viewed in real time. This provides color and quantitative mapping of liver stiffness to make it easier to detect liver disease and fibrosis in a patient, according to a press release. The new probe provides an assessment of the liver echostructure, enabling the expansion of possibilities for patients with liver disease. Using Angio PL. U.S. and contrast mode, clinicians will be able to “visualize the vascularization and micro-vascularization” of liver lesions. The fusion and navigation will also enable ultrasound images to merge with other imaging techniques, such as magnetic resonance or computed tomography.

The breast package combines multiple probes, including a TriVu mode that combines anatomical, stiffness and Angio PL. U.S. microvascularization information.

“This mode will offer a comprehensive visualization of breast lesions that had never been proposed in the field of ultrasound,” according to SuperSonic.

Disclosure: Souquet is employed by SuperSonic Imagine.

SuperSonic Imagine announced the FDA granted 510(k) clearance to add additional imaging probes — for liver disease and breast lesions — for use with its Aixplorer platform.

Aixplorer (SuperSonic Imagine) is an ultrasound system that uses an UltraFast (SuperSonic Imagine) platform for the acquisition of images at a rate 200 times faster than other ultrasound systems. The clearance includes the following imaging modes to be used with the system: PlaneWave UltraSensitive Imaging (SuperSonic Imagine), TriVu, fusion and navigation, contrast liver imaging and B-mode Ratio, according to a press release.

“These new imaging modes provide unique information for the clinical management of patients with breast and liver disease,” Jacques Souquet, founder and chief innovation officer at SuperSonic Imagine, said in the release. “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 [nonalcoholic fatty liver disease] to [hepatocellular carcinoma].”

The Aixplorer system currently allows liver anatomy to be viewed in real time. This provides color and quantitative mapping of liver stiffness to make it easier to detect liver disease and fibrosis in a patient, according to a press release. The new probe provides an assessment of the liver echostructure, enabling the expansion of possibilities for patients with liver disease. Using Angio PL. U.S. and contrast mode, clinicians will be able to “visualize the vascularization and micro-vascularization” of liver lesions. The fusion and navigation will also enable ultrasound images to merge with other imaging techniques, such as magnetic resonance or computed tomography.

The breast package combines multiple probes, including a TriVu mode that combines anatomical, stiffness and Angio PL. U.S. microvascularization information.

“This mode will offer a comprehensive visualization of breast lesions that had never been proposed in the field of ultrasound,” according to SuperSonic.

Disclosure: Souquet is employed by SuperSonic Imagine.