FDA批准510（k）清除新的超声模式为肝脏，乳房成像

StephenW

FDA grants 510(k) clearance to new ultrasound modes for liver, breast imaging
November 22, 2016

  
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.

StephenW

FDA批准510（k）清除新的超声模式为肝脏，乳房成像
2016年11月22日

  
SuperSonic Imagine宣布FDA批准510（k）清除添加额外的成像探针 - 肝病和乳腺病变 - 用于其Aixplorer平台。


Aixplorer（SuperSonic Imagine）是一种超声系统，使用UltraFast（超级成像）平台以超过其他超声系统200倍的速度采集图像。该间隙包括以下成像模式用于该系统：PlaneWave超敏成像（超声波成像），TriVu，融合和导航，对比肝成像和B模式比率，根据新闻稿。

“这些新的成像模式为乳腺和肝脏疾病患者的临床管理提供了独特的信息，”超音速Imagine创始人和首席创新官Jacques Souquet在发布会上说。 “特别是，这一新版本将把超声波Imagine定位为慢性肝脏疾病管理领域的领先创新者，涵盖从[非酒精性脂肪性肝病]到[肝细胞癌]的所有肝脏疾病。

Aixplorer系统目前允许实时观察肝脏解剖。这提供了颜色和肝硬度的定量映射，以便更容易检测患者的肝脏疾病和纤维化，根据新闻稿。新的探针提供了肝脏回声结构的评估，从而扩大了肝病患者的可能性。使用Angio PL。美国和对比模式，临床医生将能够“可视化肝脏病变的血管化和微血管化”。融合和导航还将使得超声图像能够与其它成像技术（诸如磁共振或计算机断层摄影）合并。

乳房包装结合多个探头，包括结合解剖，僵硬和Angio PL的TriVu模式。美国微血管化信息。

“这种模式将提供从未在超声领域提出的乳腺病变的全面可视化，”根据SuperSonic。

披露：Souquet是由超音速Imagine雇用。