FDA Approves LiverMultiScan for MRI

November 13, 2015

LiverMultiScan, a device that can detect early liver disease using MRI, received FDA approval.

LiverMultiScan, a device that can detect early liver disease using MRI, received 510(k) clearance from the U.S. Food and Drug Administration, Perspectrum Diagnostics announced.

Since its introduction as a research device in 2014, LiverMultiScan 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, the company said in a release.

Perspectrum Diagnostics claims that LiverMultiScan is the only imaging test cleared to detect early-stage liver disease, offering a quantitative liver assessment in a non-invasive 15-minute MRI scan. The device analyzes the native properties of liver tissue and measures liver fat without the need for additional technology or contrast agents. The result is a highly detailed map of the whole liver, which makes it possible to precisely identify regions of disease, Perspectrum said.

“LiverMultiScan is a novel non-invasive imaging technology with the potential to dramatically change the way we approach diagnosis of liver disease,” Colonel Stephen A. Harrison, MD, FACP, FAASLD, Medical Corps USA, said in the release. “Recent published data suggest that this modality can rapidly differentiate normal liver from fibrotic non-alcoholic steatohepatitis and then accurately predict outcomes based on the liver, inflammation, fibrosis score.”[[{"type":"media","view_mode":"media_crop","fid":"43315","attributes":{"alt":"","class":"media-image media-image-right","id":"media_crop_8770959724425","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"4718","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 166px; width: 249px; border-width: 0px; border-style: solid; margin: 1px; float: right;","title":"Scan developed by LiverMultiscan that shows patient has steatohepatitis and high iron.","typeof":"foaf:Image"}}]]

The device is set for a formal launch at the 2014 American Association for the Study of Liver Disease Meeting, November 13-17, 2015 in San Francisco.

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