FDA Approves MRI Software for Fatty Liver Disease Screening

Ingrid Hein

December 04, 2017

LiverMultiScan multiparametric MRI software for the diagnosis and evaluation of patients with nonalcoholic fatty liver disease has been granted 501(k) approval by the US Food and Drug Administration, Perspectum Diagnostics, the manufacturer, announced at the Radiological Society of North America (RSNA) 2017 Annual Meeting in Chicago.

The approval will allow expansion of the liver analysis technology to other multiparametric MRI machines. The original system was approved for use with a Siemens MRI, but now works with Philips technologies and will soon be available for GE machines.

"It now works interchangeably" on different equipment, said Michael Brady, PhD, from the University of Oxford, United Kingdom, who is cofounder of Perspectum Diagnostics, the maker of LiverMultiScan. And, he added, it "is no longer in black and white only."

It is estimated that about 30% of people in the United States have nonalcoholic fatty liver disease, according to the American Liver Foundation, so the diagnosis and staging of liver diseases is increasingly important.

"This is one of the major pandemics the world is faced with," Dr Brady told Medscape Medical News. If not diagnosed and treated quickly, liver disease can rapidly progress to cirrhosis or liver cancer.

No Contrast Agent

LiverMultiScan does not require a contrast agent to produce quantitative measures of hepatic fat, iron, and fibroinflammatory. And it calculates a Liver Inflammation and Fibrosis score and generates a full-color user-friendly diagnostic report on the whole liver slice image.

"The measurements we make are reproducible and standardized for the iron content and fibroinflammatory disease," Dr Brady reported.

LiverMicroScans with high (left), medium (center), and low (right) corrected T1 scores.

To help clinicians and patients understand the progression of disease on a case-by-case basis, it uses T1 and T2* mapping sequences to analyze and plot data in relation to global statistics.

LiverMultiScan is one of several MRI systems that provide noninvasive diagnoses. The current gold standard for staging liver fibrosis, FibroScan, measures shear wave velocity as it passes through the liver, but it has technical limitations for patients who are morbidly obese or who have large amounts of chest wall fat.

In a comparison of the LiverMultiScan and FibroScan systems presented earlier this year at the International Liver Congress, investigators, led by Stephen Harrison, MD, from Pinnacle Clinical Research in San Antonio, concluded that both systems are "very good imaging modalities to noninvasively assess fibrosis in NAFLD."

Dr Brady is cofounder of Perspectum Diagnostics, the maker of LiverMultiScan. Dr Harrison is medical director of Pinnacle Clinical Research.

Follow Medscape on Twitter @Medscape and Ingrid Hein @ingridhein

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