Image management system and workflow platform for digital pathology PathPresenter has announced 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 www.pathpresenter.com/clinical-care/.