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. The certification covers the company’s QMS and full technical documentation for the X100 and X100HT platforms, including its Full-Field Peripheral Blood Smear (FF-PBS) Application with RBC AI-powered decision support. By meeting these rigorous EU standards, Scopio solidifies its position as a pioneer in Full-Field digital cell morphology, ensuring its technology meets the world’s most stringent medical device safety standards.

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