Regulatory milestone clears product for use in primary diagnosis
MONTVILLE, NJ / ACCESS Newswire / June 24, 2025 / PathPresenter (www.pathpresenter.com), 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," 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 revolutionize healthcare, and we're proud to offer our robust, secure, and now FDA-cleared solutions to help practitioners and ultimately patients."
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.
To learn more about the PathPresenter platform for clinical use, visit https://www.pathpresenter.com/clinical-care/.
About PathPresenter
PathPresenter is an enterprise image management and workflow platform for digital pathology. We are on a mission to democratize access to the world's pathology knowledge by connecting pathologists to the vast expertise of their colleagues globally and providing a practical platform to access and use best-in-class AI models. Founded by dermatopathologist and digital pathology pioneer Dr. Rajendra Singh, PathPresenter's clinical viewer has been granted FDA 510(k) clearance for primary diagnosis when paired with qualified digital scanners and its secure, scalable, vendor-agnostic enterprise pathology workflow software has been adopted by tier one medical institutions for clinical care, education, and research. The company has built a thriving community of tens of thousands of users around the world to easily view and share digital pathology images and knowledge. Learn more at www.pathpresenter.com.
Media Contacts
Neil Humphrey, VP of Marketing
neil@pathpresenter.com
+1 519 498 3402
SOURCE: PathPresenter
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/pathpresenter-receives-fda-510k-clearance-for-digital-pathology-clini-1042138
