Canadian Regulators OK Pramana’s Digital Pathology Scanners

Pramana has secured Health Canada Medical Device Licenses for its flagship digital pathology scanners, the SpectralM and SpectralHT Cubiq systems. The approval allows Pramana to import, market, and sell its devices in Canada, expanding access to its advanced imaging and workflow solutions.

The Health Canada authorization enables Pramana to support Canadian hospitals, pathology labs, and research institutions, helping modernize diagnostic workflows with scalable, artificial intelligence (AI)-powered digital pathology tools.

“Receiving Health Canada authorization is a major milestone in our commercialization strategy,” Pramana Chief Product Officer Prasanth Perugupalli stated. “It reflects the strength of our product development, quality, and regulatory readiness, and it opens the door to expanding access to our technology in a market known for strong clinical and academic institutions.”

Pramana’s scanners are designed to digitize numerous pathology slides, producing high-resolution whole-slide images with automated quality control and AI-powered decision support. The platform supports both FFPE tissue and Liquid Based Cytology (LBC) samples prepared using methods such as the ThinPrep Pap test (Hologic) and BD SurePath (Becton Dickinson). Unlike most digital pathology systems focused solely on anatomic pathology, Pramana expands digital workflows to include hematopathology, microbiology, and cytology, delivering flexibility across all major slide types.

“Our research at the University of Toronto highlights the need for adaptable platforms that can manage these technical demands while still supporting routine histology and cytology workflows,” said Dr. Carlo Hojilla, consultant pathologist at the University of Toronto. “Pramana’s technology meets that standard, and its Health Canada authorization reflects both its clinical utility and the rigorous quality required for widespread adoption.”

Before it received Health Canada authorization, Pramana secured Medical Device Single Audit Program (MDSAP) certification, a requirement that validated its quality management system and streamlined regulatory access in Canada, the United States, Brazil, Australia, and Japan.

Pramana is a health tech company transforming digital pathology with AI-powered imaging solutions that support seamless adoption across labs, health systems, and medical centers. The Cambridge, Mass.-based firm’s Spectral scanners deliver image quality and accuracy. Built-in AI algorithms and automated quality control streamline workflows, increase efficiency, and capture previously undetectable tissue features, empowering pathologists with the tools needed to improve clinical diagnostics and research.