Scopio Labs Achieves EU IVDR Certification for AI-Powered Full-Field Digital Morphology Platforms

PARSIPPANY, N.J., Feb. 25, 2026 /PRNewswire/ -- Scopio Labs today announced it has achieved IVDR certification from BSI, a major regulatory milestone that clears the path for its AI-driven digital morphology platforms in the European Union

This latest milestone strengthens Scopio’s global regulatory foundation, building on the company’s recent FDA clearance for its Red Blood Cell (RBC) Decision Support System. By meeting all applicable regulatory requirements, these approvals confirm the safety and performance of Scopio’s digital morphology portfolio as it expands into key international markets.

The Full-Field PBS Application transforms how laboratory professionals conduct peripheral blood smear reviews. By providing high-resolution, dynamic digital images, the platform allows for the comprehensive evaluation of white cells, red cells, and platelets. While Scopio’s AI-powered Decision Support System was previously centred on WBC analysis, it now includes RBC morphology and platelet clump detection across the entire sample—including the feathered edge. These enhancements drive clinical consistency and efficiency while ensuring that final diagnostic decisions remain firmly in the hands of qualified experts.

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