Scopio Labs Receives IVDR Certification for AI-Driven Digital Morphology Platforms

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

On February 25, 2026, Scopio Labs celebrated a significant achievement with the announcement of its IVDR (In Vitro Diagnostic Regulation) certification by BSI. This milestone represents a major regulatory step that paves the way for Scopio's cutting-edge AI-driven digital morphology platforms within the European Union. The certification encompasses the company's Quality Management System (QMS) and comprehensive technical documentation for its platforms, the X100 and X100HT, particularly highlighting its Full-Field Peripheral Blood Smear (FF-PBS) Application equipped with AI-enabled decision support.

This certification denotes compliance with the rigorous standards set forth by the European Union, solidifying Scopio Labs as a leader in the domain of Full-Field digital cell morphology. The new framework not only signifies the safety and efficacy of their innovative technology but also positions it among the highest global medical device standards. This attainment enhances Scopio’s regulatory framework and follows closely behind its recent acquisition of FDA clearance for its Red Blood Cell (RBC) Decision Support System. Together, these approvals confirm the effectiveness and safety of Scopio's digital morphology offerings as the company looks to broaden its reach in several key international markets.

The Full-Field PBS Application revolutionizes the process for laboratory professionals when conducting peripheral blood smear evaluations. By delivering high-resolution, dynamic digital imagery, this platform enables a thorough analysis of white blood cells, red blood cells, and platelets. Previously focused on white blood cell analysis, Scopio’s AI-powered Decision Support System has expanded to include RBC morphology analysis and platelet clumping detection throughout the sample, ensuring that vital areas are examined meticulously, including the feathered edge.

These advanced features not only enhance clinical efficiency but also ensure that final diagnostic choices remain firmly in the purview of certified specialists. Itai Hayut, CEO of Scopio Labs, affirmed the significance of achieving IVDR certification, remarking, "This IVDR certification signifies our dedication to regulatory excellence throughout every stage of our research and development process. With multiple FDA certifications along with IVDR certification, we are guaranteeing that hematology laboratories across the globe can integrate innovative digital solutions that comply with the world's highest standards and seamlessly align with existing workflows."

Navigating through the advancements in the IVDR framework (EU 2017/746), Scopio Labs faced more stringent requirements than the previous IVDD accreditation. Their technical documentation and systems underwent an exhaustive evaluation by a Notified Body, which assessed various aspects including analytical and clinical performance, manufacturing standards, and risk management protocols. The positive review provided confirmation of Scopio's technology robustness and the effectiveness of their Quality Management System.

Scopio Labs is unwavering in its dedication to the digital transformation of hematology; providing state-of-the-art solutions that not only boost diagnostic accuracy but also streamline laboratory operations, enhancing patient care on a global scale.

About Scopio Labs

Scopio Labs is at the forefront of transforming cell morphology analysis, presenting a spectrum of digital imaging and analysis platforms designed to assist laboratory scientists and clinicians in the prompt detection and diagnosis of blood-related medical conditions. This expediting access to life-saving treatments is critical in modern medicine.

Scopio has addressed a long-standing challenge in cell morphology: achieving high resolution without compromising the field of view. Its pioneering high-resolution images and integrated AI technology promote more efficient remote workflows within secure hospital networks, significantly improving diagnostics throughout the healthcare delivery process.

Both the Full-Field Peripheral Blood Smear Application and Full-Field Bone Marrow Aspirate Application have received FDA clearances and CE marking for operation with Scopio X100 and X100HT platforms, further establishing Scopio’s reliability in diverse regions. Please visit www.scopiolabs.com for detailed information about their groundbreaking solutions.