Quantitative Tools for Canon Medical Systems’ Aplio i800 Receives FDA Clearance

A suite of quantitative tools to assess the spectrum of liver disease (including steatosis, inflammation and cirrhosis) on Canon Medical Systems USA Inc.’s premium AplioTM i800 ultrasound system has received U.S. Food and Drug Administration (FDA) clearance. The comprehensive Liver Analysis Suite is available on the Aplio i800, and may be helpful in the assessment of liver diseases such as steatosis, non-alcoholic fatty liver disease (NAFLD) and/or non-alcoholic steatohepatitis (NASH), which are characterized by elevated levels of fat accumulation in the liver.
 
Canon Medical Systems’ Liver Analysis Suite equips clinicians with premium diagnostic imaging tools to facilitate the analysis of Fatty Liver Disease. In addition to Shear Wave Elastography imaging, the new suite adds Attenuation Imaging (ATI) and Shear Wave Dispersion (SWD), two exclusive features that allow health care providers to visualize and quantify tissue attenuation and dispersion slope, which is a property related to tissue viscosity, for a more comprehensive evaluation of the liver.
 
In addition to the Liver Analysis Suite, a wider range of transducers, available on the Aplio i-series platform, have also been granted FDA clearance. On top of the ultra-high frequency transducer (24 MHz), the Aplio i-series now includes a new 22 MHz hockey stick to visualize small and narrow areas such as fingers and joints or for interoperative procedures, as well as several new transducers for abdominal 3D, OB 4D, neonatal and vascular imaging.
 
“The incidence of both viral and fatty liver disease is growing rapidly, and the impact of liver disease, at every stage, is highly significant in the United States,” said Dan Skyba, director, Ultrasound Business Unit, Canon Medical Systems USA Inc. “Canon is committed to new, non-invasive imaging technologies that put innovative tools in the hands of clinicians so that they can assess liver diseases earlier which may help improve a patient’s quality of life.”
 
Canon Medical Systems USA Inc., headquartered in Tustin, Calif., markets, sells, distributes and services radiology and cardiovascular systems, including computed tomography (CT), magnetic resonance (MR), ultrasound, X-ray and interventional X-ray equipment.
 
Canon Medical Systems Corporation develops and manufactures diagnostic imaging systems including CT, magnetic resonance imaging, ultrasound, X-ray systems and clinical laboratory systems and provides them to around 140 countries and regions around the world.