Pramana Secures Health Canada Authorization for Digital Pathology Scanners

Pramana has received Health Canada Medical Device Licenses for its flagship digital pathology systems—the SpectralM and SpectralHT Cubiq scanners—authorizing their import, sale, and use across Canada. This regulatory milestone enables the company to bring its AI-enabled pathology imaging and workflow solutions to Canadian hospitals, laboratories, and academic institutions, further advancing its global market presence.

The Health Canada approval confirms the safety, effectiveness, and quality of Pramana’s Class II medical devices. Designed to digitize a wide array of pathology slides, the scanners produce high-resolution whole-slide images with integrated quality control and AI-powered decision support. The platform accommodates both FFPE tissue and Liquid Based Cytology (LBC) samples, including those processed via ThinPrep® and SurePath™ methods, extending beyond traditional anatomic pathology to support hematopathology, microbiology, and cytology workflows.

This authorization builds on Pramana’s prior Medical Device Single Audit Program (MDSAP) certification, which demonstrates compliance with regulatory requirements in Canada, the U.S., Brazil, Australia, and Japan. The combined approvals highlight Pramana’s commitment to global quality standards and its readiness to scale internationally.

With support from clinicians such as Dr. Carlo Hojilla of the University of Toronto, who emphasized the value of adaptable systems in routine and advanced diagnostics, Pramana is positioned to support modern pathology practices across Canada and beyond.