Altris AI Receives Health Canada Approval, Reinforcing Its Position as a Globally Trusted AI Decision Support Platform for OCT Analysis

Regulatory clearance marks a pivotal milestone in Altris AI’s international expansion and its mission to bring clinical-grade AI to eye care worldwide.

10 March 2026 — Altris AI, a leading provider of AI-powered decision support for optical coherence tomography (OCT) analysis, today announced it has received approval from Health Canada | Santé Canada, Canada’s federal health regulatory authority. This clearance represents a significant step forward in the company’s global growth strategy and its commitment to meeting the highest standards of medical device safety and clinical reliability.

For a company scaling across international markets, regulatory approvals are far more than administrative milestones — they are foundational growth enablers. Health Canada approval strengthens Altris AI’s international positioning, opens new pathways for future regulatory submissions across key markets, and delivers a clear signal to the global healthcare community: Altris AI is built for real-world clinical practice.

The approval confirms that Altris AI’s clinical and technical validation withstands the rigorous scrutiny of Health Canada’s regulatory review process, which evaluated the platform across five critical dimensions: clinical evidence supporting efficacy and safety claims; risk management protocols; cybersecurity safeguards; quality management systems; and intended use claims. Each of these pillars reflects the standard that modern AI-driven medical devices must meet before being trusted in clinical settings.

Altris AI’s platform serves optometrists, ophthalmologists, and pharmaceutical organizations by providing intelligent, reliable support for interpreting OCT scans — one of the most widely used diagnostic tools in eye care. By surfacing clinically relevant findings with speed and precision, Altris AI empowers clinicians to make more informed decisions, improve patient outcomes, and increase the efficiency of ophthalmic workflows.

“This approval is external confirmation that our platform meets the standards required for medical-grade AI,” said  Maria Znamenska, Chief Medical Officer at Altris AI. “Health Canada’s review is thorough, evidence-based, and internationally respected. Receiving this clearance validates not just our technology, but the entire approach we’ve taken — building AI that clinicians can trust, in environments where accuracy is not optional.”

The Health Canada clearance follows a broader regulatory strategy that positions Altris AI as a compliant, audit-ready platform for healthcare systems worldwide. As global regulators increasingly scrutinize AI in medical devices, early and consistent compliance across multiple jurisdictions will become a decisive competitive differentiator.

Altris AI’s mission is to accelerate the transition of AI in eye care from innovation to infrastructure — not as a replacement for clinical expertise, but as a trusted decision-support layer that elevates the standard of care across every point of practice.

About Altris AI Altris AI is an AI Decision Support platform for OCT analysis, designed to support optometry, ophthalmology, and pharma with clinically validated, regulatory-compliant technology. The company is committed to expanding access to intelligent eye care diagnostics globally.