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What New MLMD Rules Mean For Canadian Teams
Health Canada’s February 2025 guidance marks a significant step in clarifying how machine learning–based medical devices will be assessed in Canada. The document outlines expectations for transparent model reporting, dataset documentation, and the submission of structured “change control” plans that track how algorithms evolve after approval. For developers, that means AI-enabled devices classed from II to IV will face more consistent evidence and monitoring requirements—fact
1 day ago


A Practical 2025 Pathway for Health AI
For Canadian teams developing artificial intelligence for health, 2025 brings both urgency and opportunity. Software as a Medical Device, or SaMD, now sits at the heart of how digital tools move from prototypes to regulated clinical products. The first decisive step is defining an intended use that accurately reflects the software’s medical purpose. That statement shapes classification, evidence requirements, and, ultimately, the path to regulatory authorization. Framing it t
Dec 9, 2025


Canadian Entrepreneurs Propel Health-Tech Momentum in 2025
Across Canada, a new generation of entrepreneurs is transforming how healthcare reaches patients. Artificial intelligence now interprets diagnostic images in minutes rather than hours, and virtual platforms are connecting clinicians with remote communities that once faced long travel times for consultations. Behind these changes lies a growing collaboration between academic research and early‑stage companies, blending scientific precision with entrepreneurial drive. Momentum
Nov 6, 2025


Canada's Health-Tech Momentum Gains Strength in 2025
Across Canada, the momentum behind digital health is accelerating as artificial intelligence and data-driven systems move from pilot studies to real hospital corridors and home-based care. Research teams are designing diagnostic software able to detect conditions within seconds, while entrepreneurs are testing devices that monitor chronic illnesses from hundreds of kilometres away. This dual advance—faster insight and broader reach—is reshaping how Canadians experience medica
Nov 3, 2025


Canadian Entrepreneurs Drive the Future of AI in Health Data
Across Canada, the world of health data is changing quickly as a new wave of entrepreneurs and researchers explore how artificial intelligence can support more responsive, trustworthy digital care. From lab prototypes to early-stage startups, these ventures are rooted in a distinctly Canadian approach to innovation—one that treats privacy, transparency, and public benefit as inseparable from technological progress. Their work reflects a growing consensus that health data inno
Nov 1, 2025


Canadian Startups Driving Accessible Digital Mental Health in 2025
Across Canada, conversations about mental health have shifted from the margins to the mainstream, and with that shift has come a growing...
Oct 2, 2025
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