Pathomation announces CE-IVD mark for clinical diagnostic use of vendor neutral PMA.core software

The PMA.core tile server and the PMA.UI Pathologist User Interface can be integrated into other pathology software solutions, such as LIS/LIMS to offer a full digital pathology work suite or PACS for archiving and viewing, and even image analysis (IA) artificial intelligence (AI/ML/DL) algorithms for automated slide interpretation. With the CE-IVD mark pathologists can be confident about using digital pathology for diagnostic purposes regardless of image file formats.

“This is an important milestone for both Pathomation and the diagnostic pathology labs,” commented Pathomation COO Rudy Hovelinck. “The additional benefit of using a vendor neutral solution that can handle scanner proprietary formats offers freedom and flexibility for the lab to combine different scanner types without the hassle of using and validating all the respective image viewers. The reality today is that there is no universal slide scanner able to cover the full spectrum of sample types and staining techniques used in the labs. As a vendor neutral viewing solution, PMA.core 3.0 allows labs to combine different scanners types that are optimally suited for those parameters and have a unified viewing solution. In essence we now have a single digital microscope for the pathologist that can view every scanned image.”

PMA.core 3.0 was validated for diagnostic use in histopathology of scanned slides stained with hematoxylin and eosin (HE), immunohistochemical (IHC) stainings or in situ hybridization (ISH) and meets the validation criteria of the College of American Pathologists (Evans et al, Arch Pathol Lab Med 2021) for diagnostic use of whole slide images. Two routine pathology labs each performed an independent evaluation study to support the clinical diagnostic claim by comparing the clinical conclusions of conventional microscope diagnosis versus the digital pathology diagnosis.

About Pathomation

Pathomation was founded in Belgium in 2012 and develops digital pathology solutions for a diverse clientele ranging from pharmaceutical industry, biotech, CROs, academic teaching facilities and diagnostic pathology labs. Managing whole slide images is the core business of Pathomation and the ‘PMA’ software solutions support over 30 different proprietary file formats.

About PMA.core 3.0

PMA.core 3.0 is a software platform for managing, distributing, viewing and annotating digital images of human tissue slides, scanned using any commercially available slide scanner capable of producing whole slide images in a supported file format. It is intended as an aid to the pathologist to review and interpret digital images for the purpose of primary histopathological diagnosis, including the measurement of any distances or surface areas relevant to making a diagnosis the pathologist annotated on these images. Visit us at https://www.pathomation.com/ for more information.