Digital pathology platform registered for use in supporting primary diagnosis, opening a new market for Tribun Health and its partners

Tribun Health, a global provider of digital pathology solutions, today announced that CaloPix® 6.2.0 has been included in the Australian Register of  Therapeutic Goods (ARTG No. 531926) as a Class 1 software IVD medical device, enabling the company to expand its digital pathology offering into the Australian market.

CaloPix® is registered in Australia as a web-based software device for viewing, interpreting and managing digital images of pathological glass slides. Its  intended purpose includes supporting pathologists in the review, interpretation and management of whole slide images (WSIs) for primary diagnosis.

The registration represents an important step in Tribun Health’s international expansion and enables the company and its partners to engage Australian  pathology organizations seeking to digitize diagnostic workflows and connect pathologists, images and systems across increasingly distributed laboratory networks.

“Australia is an important market for digital pathology, with large pathology networks, geographically distributed services and a clear need for technology  that can connect diagnostic workflows across sites,” said Jean-François Pomerol, CEO of Tribun Health. “The inclusion of CaloPix in the ARTG is an important step in our international expansion and allows us to bring our experience in enterprise digital pathology to Australian laboratories and pathology organizations.”

CaloPix® provides a centralized environment for viewing, storing, retrieving, analyzing, annotating and sharing digital pathology images. Its open architecture is designed to integrate with the broader pathology ecosystem, including scanners, laboratory information systems, storage infrastructure and  third-party artificial intelligence applications.

“This milestone allows us to move from developing the Australian market to actively building opportunities with our partners and customers,” said Andreia Beyer, VP Global Marketing & Managing Director North America at Tribun Health. “Australian pathology organizations are looking beyond standalone  applications toward enterprise digital pathology environments that connect people, systems, images and AI. CaloPix gives us a strong foundation to support  that transformation.”

CaloPix® 6.2.0 is listed under ARTG No. 531926, with Icon Healthcare IP Pty Ltd serving as the Australian sponsor.

About Tribun Health
Tribun Health develops digital pathology solutions that help pathology organizations transition from glass slides to connected digital diagnostic workflows. Its  CaloPix® platform supports the management, visualization and interpretation of whole slide images and is designed to integrate with scanners, laboratory  information systems, storage platforms, and artificial intelligence solutions. CaloPix is FDA-cleared, CE-IVDR marked, and Health Canada licensed. Recognized by KLAS Research among the highest-rated Digital Pathology platforms worldwide, CaloPix® earned Best in KLAS honors for three consecutive years (2022-2024) and maintained a top-tier ranking in 2025 and 2026.