Regulatory milestone clears path for expansion in Europe

PathPresenter (www.pathpresenter.com), a leading Image Management System and workflow platform for digital pathology, is proud to announce that the PathPresenter Clinical Viewer has met the requirements of the EU In Vitro Diagnostic Regulation (IVDR 2017/746) and can now bear the CE mark. This certification clears it for clinical use in primary diagnosis in Europe.

The Clinical Viewer is a key part of PathPresenter’s vendor-agnostic digital pathology image management system (IMS), a comprehensive platform that includes not just slide viewing, but also workflow management, case tracking, image storage and archiving, integration with laboratory information systems (LIS), multi-user access, collaboration tools, and integrated remote second opinion capability.

“Successfully meeting In Vitro Diagnostic Regulation (IVDR) requirements not only affirms the rigor of our clinical viewer but also underscores PathPresenter’s readiness to operate at a global scale,” said Brian Matcheski, Head of Regulatory at PathPresenter. “Coupled with our recent FDA 510(k) clearance, this milestone reflects the growing trust in our clinical solutions and paves the way for meaningful expansion into the European and international markets.”

PathPresenter’s powerful platform, designed to facilitate viewing, sharing, and collaborating on whole slide images, has been purpose-built to bridge gaps and integrate previously siloed systems. It offers a robust, secure, tech-forward platform that takes maximum advantage of whole slide imaging and digital workflows to serve the ultimate goal of a clinician’s work: to provide the best clinical care.

To learn more about the PathPresenter platform for clinical use, visit https://www.pathpresenter.com/clinical-care/.

About PathPresenter

PathPresenter is a comprehensive, enterprise-grade digital pathology platform designed by pathologists for pathologists. It provides a vendor-neutral image management and workflow solution supporting clinical diagnosis, remote consultation, education, and research. Its Clinical Viewer has earned FDA 510(k) and CE-IVDR clearance for primary diagnosis in approved configurations. By enabling integration with best-in-class AI tools and fostering interoperability, PathPresenter helps laboratories adopt advanced digital pathology workflows confidently and efficiently. Learn more at www.pathpresenter.com

Disclaimer

The PathPresenter Clinical Viewer is a software intended for viewing and managing whole slide images of scanned glass sides derived from formalin fixed paraffin embedded (FFPE) tissue. It is an aid to pathologists to review and render a diagnosis using the digital images for the purposes of primary diagnosis. PathPresenter Clinical is not intended for use with frozen sections, cytology specimens, or non-FFPE specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using PathPresenter Clinical software. PathPresenter Clinical Viewer is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner NDPI image formats viewed on the Barco NV MDPC-8127 display device.