Scopio Labs, a developer of full-field digital imaging for haematology diagnostics, on Thursday announced its fourth US Food and Drug Administration (FDA) clearance (K243144).

This latest clearance introduces new Decision Support System (DSS) features to iScopio Labs' X100 and X100HT platforms and Peripheral Blood Smear (PBS) Application, further transforming the way laboratories analyse red blood cell (RBC) morphology and identify platelet clumps in peripheral blood smears.

The company says that this upgraded solution is designed to empower qualified haematology 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 supports greater consistency and efficiency in analysis, while maintaining the essential oversight of human experts in the diagnostic process.