Scopio Labs Secures EU IVDR Certification for the Industry-Only Full-Field Digital Bone Marrow Application

Latest Software Release Delivers DICOM Integration and Advanced Analysis Management to Meet Critical Market Requirements

PARSIPPANY, N.J., April 14, 2026 /PRNewswire/ -- Scopio Labs, the leader in Full-Field digital cell morphology, today announced it has achieved IVDR certification for its Full-Field Bone Marrow Aspirate (FF-BMA) Application. This milestone, covering both the X100 and X100HT platforms, solidifies Scopio's position as the only provider of high-throughput, Full-Field digital imaging at 100x for the most complex diagnostic procedures in hematology.

The certification follows Scopio's recent IVDR approval for its Full-Field Peripheral Blood Smear (FF-PBS) Application with RBC AI-powered decision support, establishing a unified, regulated digital workflow for hematology labs across the European Union.

The Full-Field Advantage: Cells Always in Context

Bone marrow analysis is a notoriously labor-intensive and manual process, requiring experts to choose between wide-area context at low power and cellular detail at high power. Scopio's proprietary Full-Field imaging technology eliminates this trade-off, capturing large areas of the slide in one continuous digital view at 100x oil-immersion equivalent resolution. This makes Scopio the only provider of a consecutive digital copy of the patient sample, preserving the holistic view necessary for complex bone marrow assessment.

By mirroring the glass slide experience of the manual microscope, experts pan and zoom through the digital image at 100x detail anywhere on the slide, maintaining the morphological context of the cells without ever losing their place. This "Zero-Microscope" reality ensures that focal lesions or rare cell clusters can be readily assessed and eliminates the mental load of piecing together fragmented cell images.

Scalability for Laboratories of Every Size

Scopio's FF-BMA workflow is available on both the X100 and high-throughput X100HT scanners. Operationally, the two platforms are built for the clinical reality of bone marrow review, which typically requires five to seven slides per patient case. While other systems are restricted to processing one slide at a time, Scopio supports multi-slide requirements through a 3-slide tray on the X100 or a 30-slide capacity on the X100HT. This "load- and-walk away" workflow provides scalability for labs of every size and maximizes laboratory efficiency to ensure that experts can focus on analysis rather than wait for additional slides to be scanned.

Transforming Remote Review into a Primary Operational Strategy

Traditional bone marrow review physically tethers experts to the microscope. When a specialist is at a satellite site or a different campus, the diagnostic process stalls, often requiring expensive courier services and multi-day delays to move glass slides.

Since the platform is browser-based, Scopio is the first to decouple expertise from the physical lab, transforming remote review from a secondary consult into a primary operational strategy without the need for additional software installation. By creating a 100x digital copy of the slide, Scopio allows the primary reviewer to sign out cases from any location via the secure hospital network the moment the scan is complete. Specialists can collaborate in real-time, seeing the exact same Full-Field image simultaneously. This eliminates the "geographical tax" on a laboratory's most valuable clinical resources and ensures a definitive expert-led morphology report without the wait.

Market-Mandated Enhancement: DICOM Image Export and More

Coinciding with this regulatory milestone, Scopio is launching their latest BMA software version which includes a set of enhancements designed to meet the complex needs of modern laboratories. These updates deliver specific capabilities that the market identified as imperative and mandatory for professional bone marrow review. 

Scopio is now the first to be DICOM-enabled for BMA image export, allowing digital marrow slides to live alongside surgical pathology in PACS/IMS systems to future-proof lab data and remove IT friction.

The introduction of Advanced Analysis Area Management allows the expert to freeform "lasso" the regions they require for analysis to ensure the nucleated cell differential reflects their own clinical judgment.

Finally, to further bridge the gap between analog and digital review, the release introduces extended image color compatibility with new "Cold" and "Warm" configurations. This allows laboratories to align digital images with their specific staining protocols ensuring the on-screen experience matches the visual habits developed over decades at the microscope.

"This IVDR certification confirms the robustness of our technology as we expand the standard of Full-Field digitization into key international markets," said Itai Hayut, CEO of Scopio Labs. "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".

About Scopio Labs

Scopio Labs is transforming cell morphology analysis with its suite of Full-Field digital imaging platforms. By solving the age-old trade-off between resolution and field of view, Scopio enables laboratory professionals to review, consult, and sign off on cases from anywhere on a secure network, expediting patient access to life-saving treatments.

Scopio Labs' Full-Field Peripheral Blood Smear Application is FDA-cleared and CE-marked for use with the Scopio X100 and Scopio X100HT platforms and cleared for sales in additional regions.

Scopio's Full-Field Bone Marrow Aspirate Application is CE-marked and cleared for sales in additional regions. It is not commercially available in the US for in vitro diagnostic procedures.

To learn more, visit www.scopiolabs.com

SOURCE Scopio Labs