Perspectum Diagnostics, Oxford, UK, has announced that its LiverMultiScan imaging device, which can detect early liver disease using magnetic resonance imaging (MRI), has been given 510(k) clearance from the U.S. Food and Drug Administration.
Introduced in Europe and the United States as a research device in 2014, the device has important applications in clinical research for therapies targeting treatment of a range of liver diseases. The technology is currently being used to assess primary endpoints in clinical trials for investigational therapies to treat non-alcoholic fatty liver disease and non-alcoholic steatohepatitis.
Colonel Stephen A. Harrison, MD, FACP, FAASLD, Medical Corps USA, who is conducting these trials at San Antonio Military Medical Centre, said, “LiverMultiScan is a novel non-invasive imaging technology with the potential to dramatically change the way we approach diagnosis of liver diseases such as NAFLD. Recent published data suggest that this modality can rapidly differentiate normal liver from fibrotic NASH and then accurately predict outcomes based on the liver, inflammation, fibrosis score. Further studies are warranted to confirm these findings, but we are excited about the possibilities this imaging modality offers for the future in NASH diagnostics.”
Used in the clinical management of patients with chronic liver disease, LiverMultiScan is the only imaging test cleared to detect early-stage liver disease. The technology offers a quantitative liver assessment in a 15-minute MRI scan. Analysis is based on assessment of native properties of liver tissue, accurate measurement of liver fat, and other metrics without the need for additional diagnostic technologies or contrast agents.