Virasoft Receives U.S. FDA 510(k) Clearance for ViraSight, Expanding Its Enterprise Pathology Platform
New York, NY, July 2026 — Virasoft today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (K251952) for ViraSight, the companys web-based digital pathology image viewing software. The clearance authorizes ViraSight for primary diagnosis using digital whole slide images of formalin-fixed, paraffin-embedded (FFPE) tissue scanned with the FDA-cleared Hamamatsu NanoZoomer S360MD and Leica Aperio GT450 DX whole slide imaging systems. With this milestone, Virasoft joins a select group of companies authorized to market FDA-cleared software for digital pathology primary diagnosis in the United States.
Digital pathology continues to transform the practice of pathology by enabling greater collaboration, improved workflow efficiency, broader access to subspecialty expertise, and creating the foundation for artificial intelligence and precision medicine. As laboratories accelerate their incorporation of digital workflows alongside glass slides, healthcare organizations are increasingly seeking enterprise solutions that reduce complexity while supporting the highest standards of diagnostic quality and patient care.
ViraSight is the digital pathology module within Pathora, Virasofts enterprise pathology platform. Unlike standalone digital pathology viewers, Pathora connects laboratory operations, specimen and case management, digital pathology, reporting, analytics, artificial intelligence, and enterprise interoperability within a single platform. By integrating FDA-cleared digital primary diagnosis into this ecosystem, Pathora enables laboratories to manage the complete pathology journey—from biopsy accession through diagnosis and final report—within one connected workflow.
"FDA clearance represents far more than regulatory approval for a digital pathology viewer," said Samet Ayaltı, Chief Executive Officer of Virasoft. "It validates our commitment to developing enterprise software that meets the highest standards of quality, safety, and clinical performance. Innovation in healthcare requires more than new technology, it requires trust. We appreciate the professionalism and rigor of the FDA review process, which shares our goal of ensuring that innovative technologies reach clinicians only after demonstrating they are safe, effective, and reliable. We are proud that ViraSight has achieved that standard and excited to make these capabilities available to pathology laboratories across the United States."
As part of the FDA review, ViraSight successfully completed comprehensive technical performance, image quality, measurement accuracy, usability, and human factors evaluations in accordance with FDA guidance for Digital Pathology Whole Slide Imaging Devices. The FDA determined that ViraSight is substantially equivalent to legally marketed predicate devices for its intended use in primary diagnosis when used with validated scanner configurations.
The FDA clearance of ViraSight represents an important milestone in Virasofts broader vision of delivering a unified enterprise pathology platform. As pathology laboratories continue to modernize, Pathora provides healthcare organizations with a scalable digital foundation that connects laboratory workflow, digital diagnosis, reporting, analytics, artificial intelligence, and enterprise systems, assisting laboratories improve efficiency today while preparing for the future of precision medicine.
About Virasoft
Virasoft develops enterprise software that modernizes pathology laboratories through connected, interoperable digital solutions. Its flagship platform, Pathora, unifies laboratory information management, digital pathology, reporting, business intelligence, analytics, artificial intelligence integration, and enterprise interoperability into a single enterprise platform. By replacing fragmented systems with one connected ecosystem, Virasoft enables pathology laboratories to operate with greater efficiency, visibility, traceability, collaboration, and scalability while supporting the future of digital diagnostics.
Regan Baird
Chief Commercial Officer, USA
Tel: +1 (857) 928-5099