Pramana

Pramana Receives Health Canada Authorization for Digital Pathology Scanners

Regulatory milestone enables Canadian market entry and advances international expansion

Key Highlights

  • Health Canada Medical Device Licenses approved for AI-powered SpectralM and SpectralHT series systems
  • Authorization enables import, marketing, and sales of devices across healthcare organizations in Canada
  • MDSAP certification validates quality management system across multiple international markets.

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"Receiving Health Canada authorization is a major milestone in our commercialization 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."

— Prasanth Perugupalli, Chief Product Officer at Pramana

What This Means for Healthcare Providers in Canada

This regulatory milestone opens new opportunities to modernize their pathology workflows with AI-powered digital solutions.

For Hospitals & Labs

Access to Pramana's clinical-grade scanners that can support hematopathology, cytopathology, anatomic pathology, and histopathology workflows simultaneously, radically improving return on investment.

For Research Institutions

Scalable deployment capabilities for both clinical and research environments, with AI-powered decision support that captures previously undetectable tissue features.

Regulatory Excellence

Prior to receiving Health Canada authorization, Pramana secured Medical Device Single Audit Program (MDSAP) certification, validating its quality management system and streamlining regulatory access across Canada, the United States, Brazil, Australia, and Japan. This builds on a strong pipeline of innovation with 23 issued and 54 pending patents across North America, Europe, and other international markets.

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