Tribun Health, a global leader in digital pathology, has received FDA 510(k) clearance for its flagship web-based image management system, CaloPix®, for use with two industry-leading whole slide imaging scanners: the Hamamatsu NanoZoomer S360 and the Leica Aperio GT450. This marks the first FDA clearance of a digital pathology solution compatible with both scanners, a significant milestone in expanding access to vendor-agnostic, enterprise-grade tools across U.S. healthcare systems.
Already trusted by over 100 hospitals and labs across Europe and Canada—and with more than 1,000 active users worldwide—CaloPix® has proven its value in demanding clinical environments. The platform holds CE marking and Health Canada approval and has been recognized three times as "Best in KLAS" for digital pathology, a global benchmark for excellence in healthcare IT.
“This is a major commercial and clinical milestone for us,” said Jean-François Pomerol, CEO of Tribun Health. “CaloPix® has earned its reputation for performance and reliability in complex clinical workflows. With FDA clearance, we’re now well-positioned to bring our trusted solution to hospitals and laboratories across the U.S., addressing a critical need for scalable digital pathology infrastructure.”
CaloPix® is designed for the modern pathology lab, combining advanced features with a web-based, zero-footprint architecture that requires no local installation. Key capabilities include:
High-throughput case management and diagnostic reporting to streamline workflows
Seamless integration with Laboratory Information Systems (LIS) and Vendor Neutral Archives (VNA)
Telepathology and real-time collaboration tools for second opinions and multi-site consultations
Cloud readiness for flexible deployment and scalability
Robust archiving and quality control to meet regulatory and research needs
The U.S. healthcare system faces a mounting imbalance between increasing pathology workloads and a declining workforce. Simultaneously, the push for integrated diagnostics, multi-site collaboration, and precision medicine is accelerating. CaloPix® is uniquely positioned to support these demands, enabling healthcare providers to digitize workflows at scale, enhance reporting accuracy, and prepare for AI integration through structured, interoperable data.
With this latest clearance, Tribun Health is set to scale its impact in the U.S.—the world’s largest healthcare market—building on proven success with cancer centers, academic institutions, public health networks, and private labs across Europe and Canada.
CaloPix® is CE-marked, Health Canada-cleared, and FDA-cleared. Refer to IFU for intended use.