Perspectum Diagnostics said this week that it won 510(k) clearance from the FDA for its biliary visualization software, MRCP+.
The company’s AI-powered software is designed to provide improved visualization, monitoring and reporting of intra-hepatic ducts.
The metrics produced by MRCP+ could be particularly useful for doctors monitoring patients with primary sclerosing cholangitis, according to Perspectum – the company scanned more than 140 people with PSC in designing and validating the software.
“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,” Martine Walmsley, chair of trustees for PSC Support, said in prepared remarks.
“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,” founder, chairman & image analysis lead of Perspectum, Michael Brady, added.