CAMBRIDGE, Mass. — Pramana, an AI-driven health tech company focused on transforming pathology workflows, has received Health Canada Medical Device Licenses for its flagship digital pathology scanners, the SpectralM and SpectralHT Cubiq systems. The authorization clears the way for Pramana to market and sell its devices in Canada, marking a key regulatory milestone in the company’s global expansion efforts.
The Health Canada approval, required for Class II medical devices, affirms the safety, effectiveness, and quality of Pramana’s systems. With this clearance, the company aims to support Canadian hospitals, research institutions, and pathology labs with scalable digital tools designed to modernize diagnostics through AI-powered imaging and workflow solutions.
“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 produce high-resolution whole-slide images with automated quality control and AI-enhanced decision support. The systems are capable of digitizing both FFPE tissue and Liquid Based Cytology (LBC) samples, including those prepared using ThinPrep® Pap tests and BD SurePath™. Unlike many traditional platforms focused solely on anatomic pathology, Pramana’s technology supports hematopathology, microbiology, and cytology, offering broader adaptability.
Dr. Carlo Hojilla, Consultant Pathologist at the University of Toronto, highlighted the platform’s versatility: “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. 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 securing this regulatory clearance, Pramana received certification through the Medical Device Single Audit Program (MDSAP), validating its quality management system across several major markets including the United States, Brazil, Australia, and Japan.
