Pathpresenter receives FDA 510(K) clearance for digital pathology clinical viewer

PathPresenter, a leading Image Management System and workflow platform for digital pathology, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the PathPresenter Clinical Viewer for the purpose of primary diagnosis. This clearance has been issued for use with the Hamamatsu NanoZoomer S360MD Slide scanner NDPI image formats viewed on the Barco NV MDPC-8127 display device.

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.

Achieving this important regulatory milestone signals PathPresenter's dedication to providing pathologists, institutions and laboratories with the best digital tools.

This FDA clearance continues our momentum to help advance the adoption of digital workflows in pathology. Digital pathology enables the kind of precision medicine that has the potential to revolutionize healthcare, and we're proud to offer our robust, secure, and now FDA-cleared solutions to help practitioners and ultimately patients."

Patrick Myles, CEO, PathPresenter

Pathology is the bedrock of clinical decision-making, guiding nearly 70% of healthcare decisions. PathPresenter's powerful platform, designed to facilitate viewing, sharing, and collaborating on whole slide images, has been purpose-built to bridge gaps, integrate previously siloed systems, and offer 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.