Regulatory milestone enables Canadian market entry and advances international expansion

Pramana, an AI-enabled health tech company modernizing the pathology sector, today announced it has received Health Canada Medical Device Licenses for its flagship digital pathology scanners, the SpectralM and SpectralHT Cubiq systems. The approval authorizes Pramana to import, market, and sell its devices in Canada, expanding access to its advanced imaging and workflow solutions.

Health Canada authorization is required to commercialize Class II medical devices and affirms the product’s safety, effectiveness, and quality. The approval opens the door for Pramana to support Canadian hospitals, pathology labs, and research institutions, helping modernize diagnostic workflows with scalable, AI-powered digital pathology tools. This recognition marks a critical step in Pramana’s international expansion, building on its growing regulatory footprint.

“Receiving Health Canada authorization is a major milestone in our commercialization strategy,” said Prasanth Perugupalli, Chief Product Officer at Pramana. “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 a wide range of 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.”

Prior to receiving 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, highlighting Pramana’s commitment to modernizing digital pathology worldwide.

To discover how Pramana’s whole-slide imaging solution can help healthcare organizations across Canada, visit explore.pramana.ai/health-canada.

About Pramana, Inc.

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. Pramana's Spectral scanners deliver industry-leading image quality and unprecedented 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. The company is headquartered in Cambridge, Mass. For more information, visit pramana.ai.

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