Scopio Labs Receives Fourth FDA Clearance, Elevating Digital Morphology with Enhanced AI-Powered RBC and Platelet Capabilities

TEL AVIV, Israel, July 10, 2025 /PRNewswire/ -- Scopio Labs, a trailblazer in Full-Field Digital Cell Morphology, today announced another significant milestone: its fourth U.S. Food and Drug Administration (FDA) clearance (K243144). This latest clearance introduces powerful new Decision Support System (DSS) features to its X100 and X100HT platforms and Peripheral Blood Smear (PBS) Application, further transforming the way laboratories analyze red blood cell (RBC) morphology and identify platelet clumps in peripheral blood smears.

This important clearance builds on Scopio Labs' proven track record of innovation, enhancing its already FDA-cleared Full-Field Peripheral Blood Smear (PBS) Application. The upgraded solution is designed to empower qualified hematology lab professionals and enhance their conventional analysis methods by examining thousands of cells and providing intelligent, AI-driven analysis and grading for 23 distinct RBC morphology parameters and for the presence of platelet clumps, across the clinically relevant areas of the sample, from the monolayer to the feathered edge. This leap forward supports greater consistency and efficiency in analysis, while crucially maintaining the essential oversight of human experts in the diagnostic process.

"These enhancements bring added consistency and efficiency to digital morphology review," said Itai Hayut, CEO at Scopio Labs. "With this FDA clearance, we're proud to extend access to our decision support capabilities to US-based hematology labs, supporting clinical teams with solutions that align seamlessly with established workflows"

The Scopio Full-Field PBS Application, integrated with the X100 and X100HT platforms, continues to deliver comprehensive digital imaging, detecting, displaying and classifying the different blood cells. It assists hematology lab professionals in critical tasks such as WBC differentials, RBC morphology evaluation, and platelet estimates. This new clearance ensures that while AI provides valuable insights, the final decision remains confidently in the hands of the trained professional.

Scopio Labs is dedicated to driving the digital transformation of hematology labs, providing cutting-edge solutions that elevate diagnostic precision, streamline lab operations, and ultimately enhance patient care globally.

About Scopio Labs:

Scopio Labs is the developer of full-field digital imaging for hematology diagnostics. By supporting laboratory scientists and clinicians with unprecedented scale and depth in digital cell morphology, the company's platforms enable timely detection 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, 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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SOURCE Scopio Labs