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.
Altris AI is the leading multi-pathology AI Decision Support system that detects, quantifies, and tracks 40+ retinal biomarkers and 30+ retinal pathologies on OCT. Altris AI analyzes the most widespread retinal conditions, such as AMD, GA, DR, DME, and glaucoma, as well as rare conditions, such as MacTel Type 2.
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.
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.”
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