US-based medical equipment manufacturer Pramana has received Health Canada authorisation for its digital pathology scanners, SpectralM and SpectralHT Cubiq.
The regulatory approval allows the AI-enabled health tech company to import, market, and sell its devices in Canada, expanding its reach in the digital pathology sector.
The focus on advanced imaging and workflow solutions aims to modernise diagnostic processes in Canadian medical facilities.
Health Canada authorisation is crucial for commercialising Class 2 medical devices, ensuring safety, effectiveness, and quality.
The approval enables Pramana to support Canadian hospitals, pathology labs, and research institutions with scalable, AI-powered digital pathology tools.
Pramana chief product officer Prasanth Perugupalli said: “Receiving Health Canada authorisation is a major milestone in our commercialisation strategy.
“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 engineered to digitise a variety of pathology slides, generating high-resolution whole-slide images with automated quality control and AI-driven decision support.
The platform accommodates both FFPE tissue and liquid-based cytology samples, including those prepared with ThinPrep Pap test and BD SurePath.
The system extends digital workflows beyond anatomic pathology to hematopathology, microbiology, and cytology.
Before obtaining Health Canada authorisation, Pramana achieved Medical Device Single Audit Program certification.
The certification validated its quality management system and facilitated regulatory access in Canada, the US, Brazil, Australia, and Japan.
University of Toronto Consultant Pathologist Dr. Carlo Hojilla said: “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 authorisation reflects both its clinical utility, and the rigorous quality required for widespread adoption.”
Pramana is a health technology company specialising in digital pathology with AI-powered imaging solutions that support labs, health systems, and medical centres.
Earlier this year, Pramana partnered with non-profit reference laboratory ARUP Laboratories to digitise pathology slides and develop AI-powered algorithms.
The collaboration aims to improve the evaluation of bone marrow biopsies and address other diagnostic challenges in hematopathology.
