PathPresenter, an 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 management systems (LIMS), 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,” said Patrick Myles, CEO of PathPresenter. “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 revolutionise healthcare, and we’re proud to offer our robust, secure, and now FDA-cleared solutions to help practitioners, and ultimately patients.”
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.
To learn more about the PathPresenter platform for clinical use, visit www.pathpresenter.com/clinical-care.