January 24, 2019 — Perspectum Diagnostics received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MRCP+ advanced biliary visualization software.
Perspectum has developed quantitative magnetic resonance imaging (MRI) and artificial intelligence (AI) algorithms for magnetic resonance cholangiopancreatography (MRCP) images to provide improved visualization of intra-hepatic ducts, and measure the widths of bile ducts, biliary tree volume and gallbladder volume. Combining image viewing, processing and reporting tools, the metrics provided are designed to support physicians in the visualization, evaluation, monitoring and reporting of hepatobiliary structures. This is especially relevant for serial evaluation in primary sclerosing cholangitis (PSC) patients.
"I am excited by the FDA clearance of MRCP+. Non-invasive MRCP+ detection of both the numbers and diameters of strictures in patients with PSC has the potential to become a primary end point for therapeutic trials in PSC, a disease for which no effective treatments exist,” commented John M Vierling, professor of medicine and surgery, Baylor College of Medicine and former president of the American Association for the Study of Liver Diseases.
The diagnosis of PSC is hindered by lack of effective biomarkers. Interpretation of conventional MRCPs itself is both qualitative and subject to relatively low inter-operator reliability. Perspectum worked closely with patients with biliary disease to design and validate the software, scanning over 140 patients. MRCP+ has shown diagnostic potential for PSC in a study released at AASLD The Liver Meeting 2018 and is being evaluated for acute biliary imaging later this year.
Martine Walmsley, chair of trustees for the organization PSC Support, said, "The ability to diagnose and monitor the progression of PSC is needed to help develop new treatments, improve methods for cancer surveillance, and allow the early management of symptoms and complications of PSC. To this end we welcome the clearance of MRCP+ which will provide additional information for clinicians and researchers, helping address unmet need for patients with PSC."
MRCP+ is already cleared for clinical use in Europe, with CE-marking. It can process data from all 1.5T and 3T GE, Siemens and Philips MR scanners that support 3-D MRCP sequences, providing standardized quantitative metrics for the pancreatobiliary system. MRCP+ is safe, non-invasive, involves no contrast and a typical scan takes less than 15 minutes with same-day results.
For more information: www.perspectum-diagnostics.com