PathPresenter receives FDA 510(k) clearance for digital pathology clinical viewer

PathPresenter receives FDA 510(k) clearance for digital pathology clinical viewer

PathPresenter, a leading image management system and digital pathology workflow platform, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the PathPresenter clinical viewer for the purpose of primary diagnosis. This release has been issued for use with the Hamamatsu Nanozoomer S360MD grinding scanner NDPI image formats displayed on the BARCO NV MDPC-8127 display device.

The Clinical Viewer is an integral part of PathPresenter's Vendor-Agnostic Digital Pathology Image Management System (IMS), a comprehensive platform that includes not only 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 discovery capabilities.

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

This FDA clearance continues our momentum to advance the adoption of digital workflows in pathology. Digital pathology enables the type of precision medicine that has the potential to revolutionize healthcare, and we are proud to offer our robust, secure and now FDA closed solutions to help practitioners and ultimately patients. “

Patrick Myles, CEO, PathPresenter

Pathology is the foundation of clinical decision-making, guiding nearly 70% of healthcare decisions. Designed specifically for bridge gaps, PathPresenter's powerful platform, which facilitates viewing, sharing and collaboration on whole-slide images, integrates previously rare systems and provides a robust, secure, technological platform that maximizes the benefits of whole-slide imaging and digital workflows for the best clinical care.

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