Technology | Magnetic Resonance Imaging (MRI) | January 24, 2019

FDA Clears Perspectum's MRCP+ Digital Biliary Tree Viewer

First quantitative AI tool for biliary disease enables quantitative and objective assessment of the bile ducts for the first time

FDA Clears Perspectum's MRCP+ Digital Biliary Tree Viewer

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

Related Content

AIR Recon DL delivers shorter scans and better image quality (Photo: Business Wire)

AIR Recon DL delivers shorter scans and better image quality (Photo: Business Wire).

News | Artificial Intelligence | May 29, 2020
May 29, 2020 — GE Healthcare announced U.S.
Largest case series (n=30) to date yields high frequency (77%) of negative chest CT findings among pediatric patients (10 months-18 years) with COVID-19, while also suggesting common findings in subset of children with positive CT findings

A and B, Unenhanced chest CT scans show minimal GGOs (right lower and left upper lobes) (arrows) and no consolidation. Only two lobes were affected, and CT findings were assigned CT severity score of 2. Image courtesy of American Journal of Roentgenology (AJR)

News | Coronavirus (COVID-19) | May 29, 2020
May 29, 2020 — An investigation published open-access in the ...
AI has the potential to help radiologists improve the efficiency and effectiveness of breast cancer imaging

Getty Images

Feature | Breast Imaging | May 28, 2020 | By January Lopez, M.D.
Headlines around the world the past several months declared that...
United Imaging's uMR OMEGA is designed to provide greater access to magnetic resonance imaging (MRI) with the world’s first ultra-wide 75-cm bore 3T MRI.
News | Magnetic Resonance Imaging (MRI) | May 27, 2020
May 27, 2020 — United Imaging's...
There were several new developments in digital radiography (DR) technology at the 2019 Radiological Society of North America (RSNA) annual meeting. These trends included integration of artificial intelligence (AI) auto detection technologies, more durable glassless detector plates, and technologies to pull more diagnostic data out of X-ray imaging. Some vendors also have redesigned their DR systems to make them more user-friendly and ergonomic. 
Feature | Digital Radiography (DR) | May 26, 2020 | By Dave Fornell
There were several new developments in digital rad...
An example of DiA'a automated ejection fraction AI software on the GE vScan POCUS system at RSNA 2019.

An example of DiA'a automated ejection fraction AI software on the GE vScan POCUS system at RSNA 2019. Photo by Dave Fornell.

News | Ultrasound Imaging | May 26, 2020
May 12, 2020 — DiA Imaging Analysis, a provider of AI based ultrasound analysis solutions, said it received a governm
A new technique developed by researchers at UC Davis offers a significant advance in using magnetic resonance imaging to pick out even very small tumors from normal tissue. The team created a probe that generates two magnetic resonance signals that suppress each other until they reach the target, at which point they both increase contrast between the tumor and surrounding tissue

A new technique developed by researchers at UC Davis offers a significant advance in using magnetic resonance imaging to pick out even very small tumors from normal tissue. The team created a probe that generates two magnetic resonance signals that suppress each other until they reach the target, at which point they both increase contrast between the tumor and surrounding tissue. Image courtesy of Xiandoing Xue, UC Davis

News | Magnetic Resonance Imaging (MRI) | May 26, 2020
May 26, 2020 — Researchers at the University of California, Davis offers a...
Researchers from Tokyo Metropolitan University have surveyed the amount of gadolinium found in river water in Tokyo. Gadolinium is contained in contrast agents given to patients undergoing medical magnetic resonance imaging (MRI) scans, and it has been shown in labs to become toxic when exposed to ultraviolet rays. The researchers found significantly elevated levels, particularly near water treatment plants, highlighting the need for new public policy and removal technologies as MRI become even more commonp

Samples were taken along rivers around Tokyo. Measurements of rare earth element quantities indicate a clearly elevated amount of gadolinium compared to that in natural shale. Graphics courtesy of Tokyo Metropolitan University

News | Magnetic Resonance Imaging (MRI) | May 26, 2020
May 26, 2020 — Researchers from Tokyo Metropolitan...