Perspectum Diagnostics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for MRCP+, a quantitative biliary imaging tool which uses computational techniques to enhance MRCP images.
Perspectum has developed MRI and AI algorithms for MRCP images to offer improved visualization of intra-hepatic ducts and measure the width of bile ducts, biliary tree volume and gallbladder volume.
The metrics, with combined image viewing, processing and reporting tools, have been designed to support physicians in visualizing, evaluating, monitoring and reporting hepatobiliary structures. This is especially relevant for serial evaluation in Primary sclerosing cholangitis (PSC) patients.
Perspectum noted that diagnosing PSC is hindered by lack of effective biomarkers. Interpreting conventional MRCPs in itself is qualitative and is subject to lower inter-operator reliability.
The company claims to have worked with over 140 patients with biliary disease to design and validate the software and scanning.
MRCP+ is claimed to have shown the diagnostic potential for PSC in a study released at last years American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2018. It is being evaluated for acute biliary imaging later this year.
The software has secured CE-Marking, for marketing in Europe. Perspectum claims that it can process data from all 1.5T and 3T GE, Siemens and Philips MR scanners that support 3D MRCP sequences, offering standardized quantitative metrics for the pancreatobiliary system.
MRCP+ involves no contrast and a typical scan takes less than 15 minutes and offers same day results.
National Consortium of Intelligent Medical Imaging Executive Chairman and Perspectum Diagnostics founder, chairman and image analysis lead Sir Michael Brady said: “Perspectum develops quantitative MRI for decision support in a range of diseases in the liver and related organs. MRCP+ is one of the first examples of AI in medical imaging being used to solve unmet needs in hepatobiliary medicine.”
Perspectum Diagnostics was founded in 2012, in partnership with the University of Oxford, after a study demonstrated the potential of T1 mapping to predict liver fibrosis.