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FDA gives thumbs-up for Perspectum Diagnostics' biliary visualization software

by John R. Fischer, Senior Reporter | January 28, 2019
Health IT
The FDA has given a thumbs-up to the U.S. launch of Perspectum Diagnostics’ biliary visualization software, MRCP+.

The digital biliary tree viewer enables physicians to view, evaluate, monitor and report findings on hepatobiliary structures and is designed especially for assessing patients with a chronic liver disease called primary sclerosing cholangitis (PSC).

“The conventional procedure for diagnosing PSC consists of a combination of blood tests and standard MRCP, and sometimes even biopsy. Standard MRCP has a high rate of reading variability and PSC can sometimes be missed,” Perspectum told HCB News. “The main advantage of MRCP+ is objective and quantitative monitoring of the disease progression aiding clinical decision-making.”

PSC takes the forms of a progressive course of cholestasis, and inflammation and fibrosis of the intrahepatic and extrahepatic bile ducts. Its diagnosis, however, is limited by a lack of efficient biomarkers.

MRCP+ is safe, non-invasive and requires no contrast, with scans taking less than 15 minutes and results returned the same day. It can process data from any 1.5T and 3T GE, Philips and Siemens MR scanners that support 3D MRCP sequences, establishing standardized quantitative metrics for the pancreatobiliary system.

Perspectum designed and validated the software by working with and scanning 140 patients with biliary disease, and tested its diagnostic potential for PSC further in a study released at AASLD, The Liver Meeting 2018.

MRCP+ recently showcased the product this past November at the annual Radiological Society of North America meeting in Chicago, and considers it to build on the capabilities possessed by its predecessor, MRCP.

“MRCP+ enhances standard MRCP, providing quantitative metrics of the pancreatobiliary structure. MRCP+ may provide benefit in a range of hepatobiliary disorders,” said the company. “Accurate assessment of the biliary system is essential in diagnosis and monitoring of diseases such as PSC, PBC, and cholangiocarcinoma. It is also integral to liver transplant preparation and post-transplant evaluation.”

The software is being evaluated for acute biliary imaging later this year.

It is CE marked and will make its official debut on April 12 at EASL, The International Liver Conference 2019, in Vienna.

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