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Medical Devices / Submissions and Approvals

FDA Clears Ultrasound Diagnostic Systems From French Device Firm

Feb. 5, 2018

SuperSonic Imagine, a France-based medical device company, received FDA 510(k) clearance for its Aixplorer and Aixplorer Ultimate ultrasound diagnostic systems.

The clearance is the only one of its kind for ultrasound imaging liver disease capabilities for noninvasive clinical assessments of hepatic fibrosis and steatosis, according to the company.

The Aixplorer systems provide imaging and measures of liver and spleen stiffness in real-time.

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