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Perspectum Diagnostics gets FDA nod for LiverMultiScan MR imaging device

by Lauren Dubinsky, Senior Reporter | November 12, 2015
Medical Devices MRI Population Health X-Ray
LiverMultiscan showing images of patient liver
Perspectum Diagnostics announced today that its LiverMultiScan MR imaging device for diagnosing early liver disease received approval from the FDA. It was introduced in 2014 as a research device and is now installed at top hospitals in the U.S., Europe and Africa.

"LiverMultiscan has great potential to help doctors diagnose and treat liver disease in several ways," Dr. Rajarshi Banerjee, CEO of Perspectum Diagnostics, told HCB News. "First, clinicians may be able to identify liver disease with greater precision early, when it may be easier to treat. Second, many patients may avoid the need for invasive biopsy of the liver."

The technology will also help physicians determine which patients can benefit most from the various drugs that are being tested for efficacy in liver disease.
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LiverMultiScan is currently the only imaging service that is approved to help diagnose early liver disease, according to the company. The patient undergoes a 15 minute MR scan and the technology performs a quantitative analysis of the liver based on the properties of the liver tissue, an accurate measurement of liver fat, and other metrics.

The technology allows for as many as six patients to be tested in an hour with one MR system and with a 95 to 97 percent success rate, according to the company. Because of that, it can help hospitals reduce patient turnaround time and the need for additional tests with other methods.

Liver disease affects over 15 percent of people in the U.S. and 10 percent in the U.K. One of the main risk factors for non-alcoholic fatty liver disease (NAFLD) is obesity, and the World Health Organization predicts that there will be 700 million obese people worldwide in 2015.

LiverMultiScan is currently being assessed in clinical trials for investigational therapies to treat NAFLD and non-alcoholic steatohepatitis (NASH). According to recently published data, the device can quickly determine the difference between a normal liver and a fibrotic NASH and then accurately predict outcomes based on the liver, inflammation, and fibrosis score.

More studies are required to confirm those findings, but the researchers are excited about the possibilities that the device offers for the future of NASH diagnostics.

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