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.
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.
"This IVDR certification is a testament to our commitment to regulatory excellence at every stage of development," said Itai Hayut, CEO of Scopio Labs. "With multiple FDA clearances and IVDR certification in hand, we are ensuring that hematology labs worldwide can adopt innovative digital solutions that meet the highest global standards and integrate seamlessly into established workflows."
The IVDR (EU 2017/746) framework introduces significantly more stringent requirements than the previous IVDD. To achieve certification, Scopio's technical documentation underwent an extensive review by a Notified Body, including an evaluation of analytical and clinical performance, manufacturing controls, and risk management. This successful assessment confirms the robustness of Scopio's technology and the maturity of its Quality Management System.
Scopio Labs remains dedicated to the digital transformation of hematology, providing cutting-edge solutions that elevate diagnostic precision, streamline operations, and enhance patient care globally.
About Scopio Labs
Scopio Labs is transforming cell morphology analysis, offering a suite of digital imaging and analysis platforms that support lab scientists and clinicians with early detection and diagnosis of blood-related medical conditions, expediting patients' access to life-saving treatments.
Scopio solves cell morphology's age-old trade-off between resolution and field of view. Its high-resolution imaging and embedded AI combine for more efficient remote workflow through the secure hospital network, contributing to better diagnostics across the continuum of care.
Scopio Labs' Full-Field Peripheral Blood Smear Application and Full-Field Bone Marrow Aspirate Application are FDA-cleared and CE-marked for use with the Scopio X100 and Scopio X100HT platforms and cleared for sale in additional regions. The Full-Field Bone Marrow Aspirate Application is not commercially available in the US for in vitro diagnostic procedures.
To learn more, visit www.scopiolabs.com
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