Pramana Gains Health Canada Approval for AI-Powered Digital Pathology Scanners, Expanding Global Reach

Pramana, an AI-driven health technology company focused on modernizing the pathology industry, has announced it has received Health Canada Medical Device Licenses for its digital pathology scanners, the SpectralM and SpectralHT Cubiq systems. This regulatory approval allows the company to import, market, and sell its devices in Canada, marking a key step in its strategy to expand access to advanced imaging and workflow solutions. Health Canada authorization is necessary for commercializing Class II medical devices and confirms that the products meet strict safety, effectiveness, and quality standards. With this approval, Pramana is now positioned to support Canadian hospitals, pathology laboratories, and research institutions by providing scalable, AI-powered tools to modernize diagnostic processes. The authorization strengthens Pramana’s global regulatory presence, building on previous approvals in other key markets. “Receiving Health Canada authorization is a major milestone in our commercialization strategy,” said Prasanth Perugupalli, Pramana’s Chief Product Officer. “It underscores the strength of our product development, quality, and regulatory preparedness, and it gives us the opportunity to bring our technology to a market with strong clinical and academic institutions.” Pramana’s digital pathology scanners are designed to digitize a broad range of pathology slides, generating high-resolution whole-slide images with automated quality control and AI-assisted decision-making. The systems support both formalin-fixed paraffin-embedded (FFPE) tissue samples and Liquid Based Cytology (LBC) samples, such as those prepared using the ThinPrep® Pap test (Hologic) and BD SurePath™ (Becton Dickinson). Unlike many digital pathology systems that focus primarily on anatomic pathology, Pramana’s technology extends digital workflows to include hematopathology, microbiology, and cytology, offering greater flexibility for handling all major slide types. “This recognition aligns with our research at the University of Toronto, which shows a clear need for adaptable platforms that can meet these complex technical requirements while still supporting standard histology and cytology workflows,” said Dr. Carlo Hojilla, a Consultant Pathologist at the University of Toronto. “Pramana’s technology meets this need, and its Health Canada authorization highlights its clinical value and the high quality necessary for broad implementation.” Before securing Health Canada approval, Pramana achieved Medical Device Single Audit Program (MDSAP) certification, which validates its quality management system and simplifies regulatory access across multiple countries, including Canada, the United States, Brazil, Australia, and Japan. This certification reflects the company’s dedication to maintaining global standards in digital pathology. Healthcare organizations in Canada can learn more about how Pramana’s whole-slide imaging solution can enhance their diagnostic and research capabilities by visiting explore.pramana.ai/health-canada. Pramana is a health technology company that is transforming digital pathology through AI-powered imaging solutions. Its Spectral scanners deliver superior image quality and accuracy, with built-in AI algorithms and automated quality control that streamline workflows, improve efficiency, and uncover previously undetectable tissue details. These tools help pathologists enhance clinical diagnostics and research. The company is based in Cambridge, Massachusetts, and more information is available at pramana.ai.