The certification allows for high-resolution digital imaging of bone marrow aspirates to support hematology workflows in the European Union.
Scopio Labs announced it has achieved In Vitro Diagnostic Regulation (IVDR) certification for its full-field bone marrow aspirate application. The certification, which covers the X100 and X100HT platforms, allows for high-throughput digital imaging at 100x resolution for hematology procedures.
This regulatory milestone follows the company’s recent approval for its peripheral blood smear application, creating a regulated digital workflow for laboratories.
Digital Imaging Context
Bone marrow analysis is traditionally a labor-intensive manual process. Specialists often must choose between a wide-area view at low power or specific cellular details at high power. The proprietary imaging technology used in this application captures large areas of a slide in one continuous digital view at 100x oil-immersion equivalent resolution.
This “Zero-Microscope” approach allows experts to pan and zoom through a digital copy of the patient sample while maintaining the morphological context of the cells. By providing a consecutive digital image, the system ensures that rare cell clusters or focal lesions can be assessed without the need for manual microscopy.
Laboratory Scalability and Remote Review
The workflow is designed to accommodate the clinical requirements of bone marrow review, which often involves five to seven slides per case. The X100 platform includes a three-slide tray, while the high-throughput X100HT version features a 30-slide capacity to support larger laboratory volumes.
Because the platform is browser-based, it allows for remote review strategies. Specialists can access and sign out cases from different locations via a secure hospital network once a scan is complete. This capability enables real-time collaboration between specialists seeing the same high-resolution image simultaneously.
Software and Integration Updates
The company is also launching an updated software version that includes Digital Imaging and Communications in Medicine (DICOM) integration. This allows digital marrow slides to be stored in existing imaging systems alongside surgical pathology data.
Additional software features include:
Advanced Analysis Area Management: A tool that allows experts to manually select specific regions for analysis to ensure the nucleated cell differential aligns with clinical judgment.
Color Compatibility: New settings that allow laboratories to align digital images with specific staining protocols, matching the visual experience of traditional microscopy.
“This IVDR certification confirms the robustness of our technology as we expand the standard of Full-Field digitization into key international markets,” says Itai Hayut, CEO of Scopio Labs, in a release. “By combining the power of AI decision support with a seamless, browser-based workflow, we are decoupling expertise from geography and enabling labs to solve the global staffing crisis while elevating expert-led diagnostic precision.”
The bone marrow application is CE-marked for use in the European Union and other regions, though it is not currently available for in vitro diagnostic procedures in the US.
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