FDA OKs Perspectum Diagnostics' biliary software

Image analysis software developer Perspectum Diagnostics has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its biliary visualization MRCP+ software.

MR cholangiopancreatography (MRCP) is a noninvasive technique used in the evaluation of biliary tree anatomy. It can be challenging, however, because it is not quantitative and can have high subjectivity in reading.

MRCP+ is quantitative biliary imaging software that uses computational techniques to enhance MRCP images, according to the company. The combined image viewing, processing, and reporting tools are intended to help physicians visualize, evaluate, and report on hepatobiliary structures.

MRCP+ has received the CE Mark for clinical use in Europe.

Page 1 of 155
Next Page